Mechanically-actuated endotracheal tube cleaning device

ABSTRACT

Systems, devices, and methods are disclosed for the cleaning of an endotracheal tube while a patient is being supported by a ventilator connected to the endotracheal tube for the purpose of increasing the available space for airflow or to prevent the build up of materials that may constrict airflow or be a potential nidus for infection. In one embodiment, a mechanically-actuated endotracheal tube cleaning device is configured to removably receive a visualization member to provide cleaning of the endotracheal tube under direct visualization.

CROSS REFERENCE TO RELATED APPLICATIONS

This application is a continuation-in-part application of U.S. patentapplication Ser. No. 12/701,421, filed Feb. 5, 2010, which claims thepriority benefit under 35 U.S.C. §119(e) of U.S. Provisional ApplicationNo. 61/150,456, filed Feb. 6, 2009, the entireties of both of which arehereby incorporated by reference herein.

BACKGROUND

1. Field

This application relates generally to the cleaning of body-insertedtubes and, more specifically, to devices, systems, and methods forremoving fluids, secretions and/or other materials from a lumen of anendotracheal tube.

2. Description of the Related Art

An endotracheal tube is used in patient care to provide a clear airwaythrough the mouth, pharynx, and trachea into the tracheobronchial tree.Use of an endotracheal tube is appropriate when the integrity of theairway is, or may become, challenged due to trauma or pathology, or if apatient cannot otherwise breathe unaided. Often the endotracheal tube iscoupled to a mechanical ventilator to aid the patient's respiration, andcan be expected to remain in situ for an extended time until the patientis once again able to breathe on his own.

Endotracheal tubes are used in millions of patients around the world tosupport life after major surgery, trauma, or the development of certainsevere medical conditions such as pneumonia and sepsis. Patients withendotracheal tubes may be supported by the ventilator for days, weeks ormonths.

In certain circumstances, secretions and debris (biofilm) begin toaccumulate on the inside wall of the endotracheal tubes shortly after(e.g., within 24 hours) of initial intubation. The biofilm can containharmful bacteria (e.g., gram-negative organisms) that, if not removed ina timely and efficient manner, can be a potential nidus for infection.Endotracheal intubation is the single most important risk factor forhospital-acquired pneumonia. Intubated patients experience a muchgreater risk of developing hospital-acquired pneumonia than patients whoare not ventilated. Further, ventilator-acquired pneumonia (VAP) is theleading cause of morbidity and mortality in the intensive care unit(ICU), and once present, can double the expected mortality for affectedpatients.

In certain circumstances, VAP significantly increases the cost ofhospitalization. Tracheostomy can further increase the cost of dealingwith such conditions. As these are typically classified ashospital-acquired infections, health insurance providers may stopreimbursement for VAP. Because VAP is so prevalent for intubatedpatients, this could vastly increase the cost to health care providers.

SUMMARY

There remains a need for systems, methods and devices for the cleaningof endotracheal tubes that are effective and efficient so that the tubecleanings can be reasonably carried out on a regular and preventativebasis, rather than only when a particular problem arises. There alsoremains a need for systems, methods and devices for the cleaning ofendotracheal tubes that prevent the build up of materials, perform thecleaning quickly, and that permit sufficient airflow through theendotracheal tube during use.

Frequently, it is not practical or clinically acceptable to change outthe endotracheal tube when there is a buildup of biofilm in order toremove the endotracheal tube for cleaning. Removal and reinsertion ofthe endotracheal tube can be uncomfortable for the patient, can causeinjury to the native airway, and can put reliable control of the airwayat risk. Thus, several embodiments disclosed herein permit the cleaningof an endotracheal tube without the need to remove the endotracheal tubefrom the patient.

In accordance with several embodiments, a medical tube cleaning deviceis provided. In some embodiments, the medical tube cleaning devicecomprises an elongated member having a proximal end and a tip at itsdistal end. In some embodiments, the elongated member comprises at leastone lumen, conduit, or passage, extending within its interior along atleast a portion of a length of the elongated member. In someembodiments, the lumen extends to the distal tip of the cleaning device.In some embodiments, the lumen is not embedded within a wall of theelongated member. In some embodiments, the cleaning device comprises anexpandable structure, or expansion member, positioned along theelongated member. The expandable structure can be adapted to selectivelymove between a radially-collapsed position and one or moreradially-expanded positions. In some embodiments, the radially-expandedposition is selectable based at least in part on the inner diameter ofthe medical tube to be cleaned.

In some embodiments, the cleaning device comprises an outer sleeve, orouter sheath, positioned along an outer surface of the expandablestructure. In some embodiments, the outer sleeve is configured to form aremoval member to engage an interior surface of a medical tube when theexpandable structure is in the radially-expanded position. In someembodiments, the removal member is configured to apply a radial pressureor force to the interior surface of the medical tube in order to removebiofilm. The radial pressure applied or exerted can comprise a pressureor force sufficient to remove the biofilm without causing invaginationof the biofilm. The removal member formed by the outer sleeve can beconfigured to contact and remove debris collected on an interior surfaceof a medical tube when the cleaning device is moved relative to themedical tube. In some embodiments, the outer sleeve is flexibly adheredto the outer surface of the expandable structure.

In some embodiments; the medical tube cleaning device comprises anactuation assembly coupled to the proximal end of the elongated member.In some embodiments, the expandable structure is configured to movebetween the radially-collapsed position and the one or moreradially-expanded position by manipulation of the actuation assembly(e.g., squeezing of a trigger). In accordance with several embodiments,the expansion and collapse of the expandable structure occursmechanically.

According to several embodiments, a non-inflatable,mechanically-actuated cleaning device for removing biofilm from aninterior wall of an endotracheal tube is provided. In some embodiments,the endotracheal tube cleaning device comprises an elongate body havinga distal end and a proximal end. In some embodiments, the distal endcomprises a distal tip. In one embodiment, the elongate body comprisesone or more interior lumens configured to receive a visualization scope.In some embodiments, the cleaning device comprises a cleaning memberpositioned at the distal end of the elongate body. In some embodiments,the cleaning device comprises a scope retention assembly coupled to theactuation assembly. The scope retention assembly can be configured toexert a static backward force on a visualization scope inserted withinthe at least one interior lumen in the direction of the distal end ofthe cleaning device.

In some embodiments, the cleaning member comprises an expansion memberand an outer sleeve (e.g., an elastomeric sleeve, other flexible sleeve,sheath or other member, etc.). The outer sleeve can form a generallycontinuous, smooth surface. In other embodiments, the outer sleeveincludes one or more gaps and/or other features. In one embodiment, theouter sleeve is generally porous and/or forms a generally discontinuousouter surface. The cleaning member can be selectively movable between aradially-collapsed position and one or more radially-expanded positions.In some embodiments, a generally central portion of the outer sleeveforms a removal member configured to engage an interior surface of anendotracheal tube when the cleaning member is in the radially-expandedposition. The removal member can be configured to remove biofilmcollected on the interior surface of an endotracheal tube when theremoval member is moved axially within the endotracheal tube. In someembodiments, the cleaning member is configured to allow airflow throughthe endotracheal tube during cleaning. In some embodiments, anon-inflatable actuation assembly is coupled to the proximal end of theelongate body. The non-inflatable actuation assembly can providemechanical expansion of the expansion member.

In accordance with several embodiments, a method for removing debris(e.g., biofilm, other accumulations, etc.) from an interior wall of amedical tube (e.g., endotracheal tube) is provided. In some embodiments,the method comprises providing a non-inflatable, mechanically-actuatedcleaning device configured to remove biofilm from an interior wall of amedical tube. In some embodiments, the cleaning device comprises anelongate body, an expandable member, an outer sleeve and an actuationassembly. The expandable member can be positioned at the distal end ofthe elongate body. In some embodiments, the outer sleeve is positionedat least partially over an exterior surface of the expandable member.

In some embodiments, the method for removing biofilm or other debrisfrom an interior wall of a medical tube comprises inserting the distalend of the cleaning device into the medical tube while the scaffold isin a radially-collapsed position. In some embodiments, the distal tip ofthe cleaning device is shaped so as to penetrate the biofilm withoutdislodging it upon insertion of the cleaning device. In someembodiments, the method comprises mechanically actuating the scaffoldusing the actuation assembly to expand the scaffold from theradially-collapsed position to a radially-expanded position, therebyexpanding the outer sleeve to form a generally smooth removal memberconfigured to contact and remove debris collected on the interiorsurface of the medical tube. In some embodiments, the method compriseswithdrawing the cleaning device from the medical tube while generallymaintaining contact between the removal member and the debris todislodge at least a portion of the debris. In some embodiments, themethod comprises removing the cleaning device from the patient, therebyremoving the dislodged debris from the medical tube. In someembodiments, the debris is collected against the proximal surface of theouter sleeve as the cleaning device is withdrawn.

In some embodiments, the method for removing biofilm or other debrisfrom an interior wall of a medical tube comprises providing avisualization element (e.g., fiberoptic visualization scope) configuredfor capturing images of the interior of the medical tube and/or imagesof the distal airway beyond the distal end of the medical tube. In someembodiments, the medical tube comprises an endotracheal tube and thedebris comprises biofilm. In some embodiments, the method comprisesadvancing the visualization element through a lumen of the elongate bodyof the cleaning device such that the distal end of the visualizationelement engages a distal tip of the cleaning device. In someembodiments, the method comprises adjusting the position of the cleaningdevice within the medical tube at least in part based on the imagescaptured by the visualization element. In some embodiments, the methodcomprises expanding the expandable scaffold or other expandable memberto a second expanded position using the actuation assembly. In someembodiments, the method comprises verifying the removal of the debrisusing the visualization element. In some embodiments, a method forremoving biofilm from an endotracheal tube comprises a process whereinthe endotracheal tube is transformed from a tube with a 20-90% occlusionof biofilm or other material to a tube that has flow (airflow)characteristics like a brand new tube. For example, the cleaning devicecan remove about 90-95% of the biofilm collected along an inner surfaceof the endotracheal tube. In some embodiments, the visualization scopeis used to verify that the endotracheal tube has an inner diameter thatis substantially equivalent to a brand new, sterile or unusedendotracheal tube.

In accordance with several embodiments, the expansion member, expandablemember, or expandable structure, comprises an expandable mesh scaffold.The mesh scaffold can comprise braided or weaved elements. The braidedor weaved elements can comprise one or more polymeric and/or metallicmaterials. In other embodiments, the expansion member, or expandablestructure, comprises a strut assembly or a bellows-like assembly. Insome embodiments, a length of the outer sleeve decreases, and theremoval member comprises a generally smooth apex when the expandablestructure is in the radially-expanded position, wherein the generallysmooth apex is configured to contact an inside surface of the medicaltube (e.g., endotracheal tube). In some embodiments, the expansionmember is configured to expand the outer sleeve (e.g., elastomericsleeve) to form a disc-like removal member in the radially-expandedposition. In some embodiments, the removal member comprises a generallydiamond-shaped removal member having generally smooth or rounded apexes,which forms the contact surface of the removal member. In someembodiments, the removal member comprises a removal member having alongitudinal half cross-section that is generally bell curve-shaped(e.g., Gaussian distribution curve) having a smooth apex and a generallysteep slope. For example, the width of the removal member formed on theouter sleeve can be narrow at the point of contact with the endotrachealtube and taper sharply toward the longitudinal axis of the cleaningdevice. In some embodiments, the slope of the removal member isgenerally or substantially vertical. The disc-like removal member can beformed due to an increased radial pressure over a concentrated length ofthe outer sleeve. In some embodiments, the disc-like removal memberadvantageously prevents or minimizes hydroplaning as it is pulledthrough or adjacent the biofilm.

In some embodiments, the removal member is formed as a result of theproperties and characteristics of the materials selected for thescaffold and/or outer sleeve. In several embodiments, the removal memberhas a side cross-sectional or side view (when viewed from the side ofthe cleaning device) that is bell-shaped (half-section), tent-shaped(half-section), triangular-shaped (half-section), diamond-shaped(full-section), or disc-shaped (full-section). For example, for adiamond-shaped or disc-shaped removal member, the top and bottom apexescan be generally rounded. Further, for any of the sleeve embodimentsdisclosed herein, the removal member can have generally vertical and/orsloped sides along one or both sides of the top or bottom apex. Inaddition, for any of the embodiments disclosed herein, the removalmember, as viewed from the side or in cross-section, can be generallysymmetrical about an axis perpendicular to the adjacent wall of theendotracheal tube or other medical tube being cleaned. In otherembodiments, the removal member can be asymmetrical about such an axis.The side cross-sectional view can be taken by cutting (e.g.,hypothetically) the removal member formed on the outer sleeve in halffrom the proximal end to the distal end along the longitudinal axis ofthe elongated body and viewing the removal member from the side of thecleaning device. In some embodiments, bell-shaped and tent-shaped refersto the shape of the upper half-section or lower half-section of agenerally diamond-shaped removal member.

Disc-shaped, as used herein, shall be given its ordinary meaning andshall include shapes that are generally circular in geometry, including,but not limited to, frisbee-shaped, plate-shaped, ellipse-shaped, andoval-shaped. Disc-shaped structures shall also include, but not belimited to, structures that have two opposing ends (e.g., flat orplanar), wherein each end has a length and a width (for example in acircular disc, the length and width would both be diameters), andwherein the structure has a thickness or height between the two opposingends, wherein the thickness or height is less than (e.g., by at least30%, 50%, 75%, 90% or more) at least one of the length and width of eachend. In one embodiment, the disc-shaped structure is non-cylindrical. Inone embodiment, the disc-shaped structure has one or more axes ofsymmetry. In one embodiment, the disc-shaped structure is asymmetrical.In one embodiment, the two ends are substantially identical, while inother embodiments, the two ends are sized and/or shaped differently. Inseveral embodiments, the disc-shaped structure has one or more openings(or apertures) that extends from one end through the other end (e.g., asin an O-ring), or through one end only. In several embodiments, thedisc-shaped structure does not have an opening. Other shapes are alsoprovided in some embodiments. In some embodiments, the sidecross-section (cut along the longitudinal axis of the elongate body ofthe cleaning device from the proximal end to the distal end) iscontoured, concave, oblong, triangular or square.

In some embodiments, the removal member has an apex and a base (e.g., onone side of a two-sided structure), wherein the ratio of the apex:baseis about 1:2, 1:3, 1:4, 1:5, 1:6, 1:7, 1:8, 1:9 and 1:10, or higher. Forexample, the apex is about 0.02-0.5 inches and the base is about 0.04 toabout 2 inches in some embodiments, (e.g., about 0.1-0.2 inches at theapex and about 0.3 to about 0.8 inches at the base). Smaller or largerapices and/or bases may be used depending on the size of the tube thatneeds cleaning. The apex may be rounded, squared, or pointed. In oneembodiment, the removal member has a single base with two apices. Insome embodiments, the ratio of the width of the removal member to theoverall length of the outer sleeve in the radially-expanded position isabout 1:10 to about 2:5 (e.g., about 1:10, 1:9, 1:8.5, 1:8, 1:7, 1:6,1:5.5, 1:5 1:4, 1:3, 2:5, etc.). In some embodiments, the ratio of thewidth of the removal member to the overall length of the outer sleeve inthe radially-expanded position is between about 1:8.5 and about 1:5.5.In other embodiments, the ratio of the width of the removal member tothe overall length of the outer sleeve is less than about 1:10 orgreater than about 2:5. In some embodiments, the width of the removalmember is about 1 mm to about 10 mm (e.g., 4 mm to 7 mm, 4.5 to 6.3 mm,3 mm to 6 mm, etc.). However, in other embodiments, the width of theremoval member is less than about 1 mm or greater than about 10 mm. Insome embodiments, the length of the outer sleeve when the expandablestructure is in the radially-expanded position is about 63% (e.g., about50-85%, about 55-75%, about 60-70%, etc.) of the length of the outersleeve when the expandable structure is in the radially-collapsedposition. In some embodiments, the length of the outer sleeve when theexpandable structure is in the radially-expanded position is greaterthan about 85% or less than about 50% of the length of the outer sleevewhen the expandable structure is in the radially-collapsed position. Insome embodiments, the length of the outer sleeve decreases by about 15to about 50% upon expansion of the expandable structure. In someembodiments, the length of the outer sleeve decreases by between about 4to 24 mm (e.g., 4 to 20 mm, 8 to 16 mm, 10 to 14 mm) upon expansion ofthe expandable structure. However, in other embodiments, the length ofthe outer sleeve decreases by less than about 4 or more than about 24 mmupon expansion of the expandable structure.

According to some embodiments, for a diamond-shaped or disc-shapedremoval member, the top and bottom apexes can be generally rounded.Further, for any of the sleeve embodiments disclosed herein, the removalmember can have generally vertical and/or sloped sides along one or bothsides of the top or bottom apex. In addition, for any of the embodimentsdisclosed herein, the removal member, as viewed from the side or incross-section, can be generally symmetrical about an axis perpendicularto the adjacent wall of the endotracheal tube or other medical tubebeing cleaned. In other embodiments, the removal member can beasymmetrical about such an axis.

In some embodiments, the outer sleeve is coupled or adhered to theexpansion member with flexible adhesive. The inner diameter of the outersleeve (e.g., elastomeric sleeve) can be less than the outer diameter ofthe expansion member, thereby forming an interference fit. In someembodiments, the outer sleeve comprises silicone. In some embodiments,the cleaning member comprises one or more cutouts, recesses, ports,vents, openings, or gaps on each side of the cleaning member tofacilitate the flow of air across the cleaning member. For example, aircan flow through the interstices of the expansion member, or expandablestructure, from the air gap on one side of the cleaning member to theair gap on the other side of the cleaning member.

In accordance with several embodiments, a mechanically-actuated cleaningdevice is provided for removing biofilm from an interior surface of amedical tube. In some embodiments, the cleaning device comprises anelongate body, wherein the elongate body comprises an outer shaft and aninner shaft. The inner shaft can be concentrically positioned within theouter shaft and can be configured to move coaxially within the outershaft. In some embodiments, the inner shaft comprises a lens cap mountedover a distal end of the inner shaft. In some embodiments, the cleaningdevice comprises a cleaning member positioned at a distal end of theelongate body.

According to some embodiments, the cleaning member comprises amechanically-expandable bellows member or structure that is selectivelymovable between a radially-collapsed position and a radially-expandedposition. The bellows member can comprise at least one molded removalmember extending circumferentially around the bellows member. In someembodiments, the bellows member comprises one or more air vents oropenings configured to allow airflow across the bellows member duringuse. The bellows member can be concentrically mounted about the innershaft such that a distal end of the bellows member is configured togenerally abut the lens cap mounted over the distal end of the innershaft and such that a proximal end of the bellows member is configuredto generally abut a distal end of the outer shaft.

In some embodiments, the cleaning device comprises an actuation assemblycoupled to a proximal end of the elongate body for selectively movingthe inner shaft relative to the outer shaft, wherein relative movementof the inner and outer shafts moves the bellows member between theradially-collapsed position and the radially-expanded position. In someembodiments, when in the radially-expanded position, the removal memberof the bellows member is configured to contact and remove biofilmcollected on the interior surface of a medical tube (e.g., endotrachealtube) as the cleaning device is withdrawn from the medical tube. In someembodiments, the bellows member is non-inflatable. In some embodiments,the mechanically-expandable bellows member comprises living hinges atconnection points between a body of said bellows member and each of theproximal and distal ends of said bellows member about which said bellowsmember hinges to radially expand and collapse the molded removal member.In one embodiment, a cross-sectional dimension of the bellows membervaries across the length of the body of the bellows member. For example,the diameter of the body can gradually decrease toward the center of thebody. The bellows member can comprise one or elastomeric materials. Insome embodiments, the bellows member is not adhered to (e.g., is“free-floating” on) the inner shaft. In some embodiments, the moldedremoval member comprises a tapered ring shape or structure. The moldedremoval member can comprise a generally smooth contact surface or asqueegee-like contact surface.

In some embodiments, the cleaning device comprises a scope retentionassembly coupled to the actuation assembly. In some embodiments, thescope retention assembly is configured to exert a static backward forceon the visualization scope in the direction of a distal end of thecleaning device such that a distal end of the visualization scopegenerally remains pressed against, or in constant contact with, aviewing window at the distal end of the interior lumen of the cleaningdevice. In some embodiments, the scope retention assembly comprises ascope sheath, or tube, and a scope retention member. The scope sheath,or tube, can comprise an elastomeric sheath, or tube. The elastomericsheath can be configured to stretch to allow the scope retention memberto receive a locking member disposed on the visualization scope, therebyproviding the static backward force on the visualization scope. In someembodiments, the elastomeric sheath is stretched such that a retentionmember (e.g., locking ring) disposed on the visualization scope isreceived by a corresponding slot, groove, recess, cutout, or otherreceiving structure of the scope retention member. When the scoperetention member is released, the elastomeric nature of the elastomericsheath creates the static backward force on the visualization scope, asthe elastomeric sheath is configured to return to its normalnon-stretched state.

In some embodiments, the endotracheal tube cleaning device does notcomprise any cleaning members and is used only to view the inside of anendotracheal tube by inserting a visualization element (e.g., fiberoptic scope) having a lens at its distal end within a lumen of theendotracheal tube cleaning device. The scope retention assembly can beconfigured to exert a static backward force on the visualization elementsuch that a distal lens of the visualization element maintains a desiredspacing relative to the viewing window. In some embodiments, the distallens is maintained in generally constant contact with the viewingwindow.

In accordance with several embodiments, a method for facilitating theconversion from an endotracheal tube to a tracheostomy tube is provided.In some embodiments, the method comprises providing a multi-portconnector or adaptor (e.g., off-the-shelf T-connector or adaptor or aproprietary, specially designed or customized multi-port connector)having one or more inlet ports and one or more outlet ports. Forexample, the multi-port connector can comprise an in-line inlet port, aside inlet port, and an outlet port. In some embodiments, the outletport of the connector is coupled to a proximal end of an indwellingendotracheal tube. The connector can be configured to couple to auniversal endotracheal tube connector. In some embodiments, the methodcomprises coupling a side inlet port of the connector to an externalventilator, wherein the external ventilator is configured to deliver airthrough the outlet of the connector. In some embodiments, the connectoris used to allow for visualization of the conversion from anendotracheal tube to a tracheostomy tube. In other embodiments, theconnector is used for the initial visualization during insertion of theendotracheal tube and/or for teaching the use of the endotracheal tubecleaning device.

In some embodiments, the method for facilitating the conversion from anendotracheal tube to a tracheostomy tube comprises inserting anendotracheal tube cleaning device comprising a visualization lumen orchannel having a window at a sealed distal end into the in-line inletport of the connector. In some embodiments, the method comprisesinserting a visualization scope or other visualization member within thevisualization lumen. In some embodiments, the method compriseswithdrawing the endotracheal tube to a position such that the distal endof the endotracheal tube is adjacent (e.g., proximal or distal) to alarynx within a trachea of a patient. In some embodiments, the methodcomprises performing a percutaneous tracheostomy while visualizing thetrachea beyond the distal tip of the endotracheal tube using thevisualization scope.

In some embodiments, the method for facilitating the conversion from anendotracheal tube to a tracheostomy tube comprises inserting atracheostomy tube within the trachea under direct visualization usingthe visualization scope. In some embodiments, the method comprisesconfirming the proper positioning of the tracheostomy tube. In someembodiments, confirming the proper positioning of the tracheostomy tubecomprises analyzing images captured by the visualization scope. In someembodiments, the method comprises removing the endotracheal tube fromthe patient. In some embodiments, the method comprises coupling thetracheostomy tube to the external ventilator. In some embodiments, themethod comprises removing the visualization scope from the endotrachealtube cleaning device.

In some embodiments, method for facilitating the conversion from anendotracheal tube to a tracheostomy tube comprises coupling thevisualization scope to a display monitor, wherein images captured by thevisualization scope are displayed on the display monitor. In oneembodiment, the visualization scope is coupled to the display monitorusing an optical connection and not an RF connection or any otherwireless or hardwired connection. In some embodiments, the methodcomprises verifying proper insertion of a hollow needle within thetrachea, verifying proper insertion of a guidewire through the hollowneedle of the trachea, and/or verifying proper insertion of tracheostomydilators within the trachea over the guidewire. In some embodiments, themethod comprises recording an image of the tracheostomy tube afterinsertion. In some embodiments, the method comprises inflating a ballooncuff of the endotracheal tube after withdrawing the endotracheal tube tothe position such that the distal end of the endotracheal tube isadjacent (e.g., distal or proximal) to the patient's larynx within thetrachea. In some embodiments, air flow through the endotracheal tube isgenerally maintained during the performance of the percutaneoustracheostomy.

Some embodiments of the cleaning devices, systems and methods disclosedherein are particularly advantageous because the need for “blind”suctioning of the biofilm with a suction catheter is avoided. Thus, thevarious embodiments disclosed herein can minimize or reduce patientdiscomfort and avoids long periods of breathing interruption.

Some embodiments are advantageous because they do not employ a balloonor other seal as a cleaning member. Thus, in some embodiments, thedevices, systems and methods disclosed herein facilitate airflow throughthe endotracheal tube during cleaning. In addition, problems associatedwith rupture of the balloon or the inability to adequately deflate theballoon are avoided in some embodiments. In some embodiments, a cleaningdevice can be operated by a single user. In one embodiment, the cleaningdevice is operated by a single user using one hand. Thus, severalembodiments are particularly advantageous because of the simplicity ofone-handed operation and the reduced time needed for mechanicallyactuating the device (as opposed to inflating a balloon). In oneembodiment, the cleaning device does not require multiple passes toclean the endotracheal tube, although the device is suitable forrepeated closure and expansion if desired.

In some embodiments, the cleaning device removes harmful bacteria fromthe endotracheal tube by removing biofilm. In several embodiments, thecleaning device comprises a scaffold (e.g., mesh scaffold), or othercollection member, for trapping the harmful biofilm, thereby reducingthe vaporization or travel of harmful bacteria during the cleaningprocess.

In some embodiments, the removal of biofilm not only removes a source ofharmful bacteria, but also enhances airflow and respiration. Biofilm canaccumulate over time to a level that impairs ventilation bysignificantly reducing the cross-sectional area of the lumen of theendotracheal tube. For example, a 1 mm thick layer of biofilm in anendotracheal tube having an 8 mm inside diameter can reduce thecross-sectional area available for air flow by approximately 50%.Progressive airway occlusion within the endotracheal tube can makeweaning and extubating the patient difficult or impossible, and may leadto the need for a tracheostomy.

In several embodiments, the devices described herein are inserted to avariable, predetermined depth inside the endotracheal tube and when thecleaning member is deployed to engage the inner surface of theendotracheal tube, air exchange through the deployed cleaning member canstill occur. In some embodiments, the endotracheal tube cleaning devicehas a lockable, adjustable insertion stop that prevents the device frombeing inserted too far into the patient's ET tube, thereby avoidingpotential injury to the patient's airway.

In some embodiments, the endotracheal tube cleaning devices describedherein can accommodate a viewing element in an internal channel or lumenfor training purposes, to assess the inside surface of an endotrachealtube, and/or to determine the position of the tip of the endotrachealtube in relation to the patient's carina.

In some embodiments, the endotracheal tube cleaning devices have asimple expansion mechanism and can be manufactured from inexpensiveand/or disposable materials to keep costs low. By reducing patient carecosts, the endotracheal tube cleaning device can be used on a regularand preventative basis and not just when trouble arises.

According to some embodiments, a cleaning device has a cleaning memberthat can be rapidly deployed, the tube cleaned of build up, and thecleaning device removed in a manner such that the patient can continueto be supported by a ventilator with only the briefest interruption.

According to some embodiments, a mechanically-actuated non-inflatablecleaning device for scraping debris (e.g., biofilm) from an interiorwall of a conduit is provided. In one embodiment, the cleaning devicecomprises an elongated member having a proximal end and a distal end anda mechanically-expandable scaffold (e.g., mesh scaffold, struts, etc.)positioned along the distal end of the elongated member. Themechanically-expandable scaffold is adapted to move between aradially-collapsed position and a radially-expanded position. Further,in one embodiment, the scaffold comprises one or more removal members(e.g., O-ring, wiper, piston ring, etc.) extending outwardly (e.g.,radially) from an outer surface of the scaffold. In some embodiments,the removal member is configured to engage an interior surface of aconduit when the scaffold is in the radially-expanded position. In otherembodiments, expansion of the scaffold can be configured so that theremoval member does not contact the inside surface of the conduit. Inother embodiments, the expansion and collapse of the scaffold can beselectively regulated to easily modify the radial expansion of theremoval member coupled to the scaffold. In some embodiments, the removalmember is configured to scrape, shear, dislodge, loosen or otherwiseremove debris collected on an interior surface of the conduit when saidcleaning device is moved relative to the conduit. In severalembodiments, the scaffold comprises pores (e.g., mesh structure), otherorifices or openings and/or the like that are configured to trap thescraped debris. The cleaning device additionally includes an actuationassembly coupled to the proximal end of the elongated member. In someembodiments, the scaffold is configured to move between theradially-collapsed position and the radially-expanded position (e.g., afully radially-collapsed position, a fully radially-expanded position, apartially radially-collapsed position, a partially radially-expandedposition, etc.) by manipulation of the actuation assembly (e.g.,trigger, handle, lever, etc.). In some embodiments, the expansion andcollapse of the scaffold occurs mechanically. In some embodiments, theactuation assembly provides single action expansion and single actioncollapse of the scaffold.

In one embodiment, the removal member (e.g., one or more O-rings,wipers, etc.), scaffold (e.g., mesh scaffold), struts, ribs, mechanicalbellows, the collection member and/or any other portion of the cleaningdevice or system are configured to be actively mechanically actuatedbetween an expanded configuration and a collapsed configuration. In someembodiments, the removal member, scaffold, struts, ribs, mechanicalbellows, the collection member and/or any other portion of the cleaningdevice or system are actively mechanically actuated without the use of asheath, sleeve, covering or similar member. In another embodiment, theremoval member, scaffold, struts, ribs, mechanical bellows, thecollection member and/or any other portion of the cleaning device orsystem are non-bristled, non-inflatable and/or non-sheathed.

According to some embodiments, a non-inflatable, mechanically-actuatedcleaning device for removing biofilm from an interior wall of anendotracheal tube or other conduit comprises an elongate body having adistal end, a proximal end, a longitudinal axis and a diameter in therange of about 1 mm to about 5 mm. The cleaning device further comprisesa scaffold (e.g., mesh scaffold) positioned at the distal end of theelongate body. In some embodiments, the scaffold is positioned near theproximal end of the elongate body or at any other location along theelongate body. In one embodiment, the cleaning device comprises one ormore O-rings or other removal members coupled to the scaffold (e.g.,mesh scaffold) and a non-inflatable actuation assembly coupled to theproximal end of the elongate body for mechanically-actuating theexpansion of the scaffold. In some embodiments, the scaffold is radiallyexpandable between a collapsed position and an expanded position bymanipulation of the actuation assembly. In one embodiment, the level ofexpansion and/or collapse can be precisely controlled betweenfully-expanded and fully-collapsed positions. In several embodiments,the O-ring or other removal member is configured to engage an interiorsurface of an endotracheal tube when the scaffold is in the expandedposition. In some embodiments, the O-ring is configured to removebiofilm collected on the interior surface of an endotracheal tube whensaid O-ring is moved along the longitudinal axis of the elongate body.In one embodiment, the scaffold comprises a porous architectureconfigured for facilitating the in-flow of said biofilm into an interiorof the scaffold, thereby trapping at least a portion of the biofilmwithin the scaffold. In other embodiments, one or more portions of thescaffold are non-porous or substantially non-porous so as to prevent orreduce the likelihood of biofilm and/or other materials from passingtherethrough. In several embodiments, the scaffold (e.g., mesh scaffold)is configured to allow airflow through the endotracheal tube in thecollapsed position and the expanded position. In some embodiments, theactuation assembly is configured for one-handed manipulation of thecleaning device during a cleaning procedure.

In some embodiments, the conduit to be cleaned is a gun barrel, and thecleaning device or system comprises one or more removal members that areconfigured to remove oil, grease, oxidation, rust, mineral deposits,scale, other types of deposits, gun powder residue, other types ofcombustion residue and/or the like. In other embodiments, the conduit tobe cleaned is a pipe, duct, flue (e.g., boiler flue), exhaust conduit ortubing, and the cleaning device or system comprises one or more removalmembers that are configured to remove sludge, mineral deposits, rust,other oxidation, grease, oil, soot, biofilm, scum, scale and/or thelike.

According to some embodiments, a non-inflatable, mechanically-actuatedcleaning device for removing biofilm from an interior wall of anendotracheal tube comprises an elongate body having a distal end, aproximal end and a longitudinal axis, and a cleaning member positionedat or near the distal end of the elongate body. In some embodiments, thecleaning member is positioned near the proximal end of the elongatebody, generally between the distal and proximal ends of the elongatebody and/or at any other location along the elongate body. In oneembodiment, the distal end of the elongate body comprises a tip. In someembodiments, the cleaning member comprises a removal member and acollection member, such that the removal member is selectively movablebetween a radially-collapsed position and a radially-expanded position.In several embodiments, the removal member is configured to engage aninterior surface of an endotracheal tube when in the radially-expandedposition. In other embodiments, the removal member is configured toengage at least a portion of a biofilm layer positioned along theinterior surface of an endotracheal tube when in the radially-expandedposition. In some embodiments, the removal member is configured to beexpanded to any one of a plurality of possible expanded positions. Inone embodiment, the possible expanded positions for the removal memberare generally between a fully collapsed and a fully expanded position.

According to several embodiments, the removal member is configured toremove biofilm collected on the interior surface of an endotracheal tubewhen the removal member is moved along the longitudinal axis of theelongate body. In other embodiments, the removal member is configured toremove biofilm when it is moved relative to the endotracheal tube. Insome embodiments, the non-inflatable, mechanically-actuated cleaningdevice further comprises one or more collection members configured tocollect at least a portion of removed biofilm. In several embodiments,the collection member is configured to allow airflow through theendotracheal tube. In other embodiments, the cleaning deviceadditionally comprises a non-inflatable actuation assembly coupled tothe elongate body. In one embodiment, the actuation assembly is locatedat or near the proximal end of the elongate body. According to someembodiments, the removal member is movable between theradially-collapsed position and the radially-expanded position bymanipulation of the actuation assembly. In another embodiment, theexpansion and collapse of the removal member occurs mechanically and notusing inflation balloons and/or other hydraulic devices or features.

In some embodiments, the outside diameter of the elongate body of thecleaning device is about 0.05 mm to about 10 mm (e.g., from about 1 mmto about 5 mm, about 2 mm to about 4.5 mm, about 2.5 mm to about 3.5 mm,about 5 mm to about 8 mm, about 8 mm to about 10 mm, or greater, andoverlapping ranges thereof). In some embodiments, the length of theelongate body is about 10 cm to about 70 cm, or greater, (e.g., fromabout 10 cm to about 20 cm, about 20 cm to about 30 cm, about 30 cm toabout 40 cm, about 40 cm to about 50 cm, about 50 cm to about 70 cm, andoverlapping ranges thereof). In one embodiment, the length of theelongate body is about 29 cm to about 45 cm.

In some embodiments, the cleaning member is positioned at, near orproximate to the distal end of the elongate body. In other embodiments,the cleaning member is positioned anywhere along the elongate body. Inseveral embodiments, the collection member comprises an expandablescaffold configured to expand the removal member into theradially-expanded position. In several embodiments, the collectionmember comprises a sleeve (an elastomeric sleeve). According to someembodiments, the collection member comprises a mesh or another memberhaving a plurality of pores, orifices or other openings. In someembodiments, the actuation assembly is configured to permit a user tomodify radial expansion of the removal member in order to modify apressure exerted by the removal member on an inside surface of anendotracheal tube or on a biofilm deposited thereon. In one embodiment,the expansion of the removal member can be varied along a spectrum orrange generally defined between a fully-collapsed positioned and afully-expanded position.

According to some embodiments, the non-inflatable, mechanically-actuatedcleaning device for removing biofilm from an interior wall of anendotracheal tube includes a cleaning device having an elongate bodywhich comprises an inner shaft and an outer shaft, such that movement ofthe inner shaft relative to the outer shaft causes the removal member tomove between collapsed and expanded radial positions. In someembodiments, the removal member is moved between a radially-collapsedposition and a radially-expanded position by deployment of at least onestrut or similar member located at or near the cleaning member. In otherembodiments, the removal member of the cleaning device comprises one ormore expandable wiper members.

According to some embodiments, the cleaning member of the cleaningdevice comprises an expandable spring or an expandable collet. Inseveral embodiments, the removal member comprises a generally smoothouter surface. In other embodiments, the elongate body of the cleaningdevice comprises at least one interior lumen that extends at leastpartially along the length of the elongate body. In some embodiments,the cleaning device additionally comprises one or more ports in theelongate body and/or the actuation assembly that provides access to theinterior lumen of the elongate body.

In some embodiments, the distal tip of the elongate body comprises aviewing window or other feature or portion through which visualizationcan occur. In one embodiment, the elongate body of the cleaning devicecomprises one or more interior lumens, channels or other openings toprovide access to a location along an exterior of the elongate body. Inother embodiments, the removal member can have one or more openings thatprovide access to a location along an exterior of the cleaning device.In some embodiments, the openings along the elongate body and/or theremoval member allow for the aspiration and/or irrigation of fluids orother materials. In several embodiments, an interior lumen or otheropening of the elongate body is configured to receive at least one of avisualization scope, an aspiration conduit, an irrigation conduit, alight therapy source or a ventilation conduit. In some embodiments,catheters or other instruments configured to be positioned through oneor more lumens of the elongate body or other portion of the cleaningdevice comprise ultrasonic catheters, radio frequency (RF) catheters,irrigation catheters, aspiration catheters, drug delivery catheters,catheters for delivering light for photodynamic or other light-basedtherapy, other types of catheters or devices, and/or combinationsthereof. In one embodiment, the elongate body comprises one or moreopenings at or near the distal tip. In other embodiments, the elongatebody comprises one or more openings near its proximal end and/or at anyother location along the length of the elongate body.

According to some embodiments, the actuation assembly is configured forone-handed manipulation of the cleaning device during a cleaningprocedure. In other embodiments, the cleaning device is configured forsingle pass cleaning. In other embodiments, the cleaning device isconfigured for multiple pass cleaning. In certain embodiments, thecleaning device is used to clean endotracheal tubes having a variety ofdiameters and lengths. In some embodiments, the removal member ispositioned along an exterior surface of the collection member. In oneembodiment, the removal member is positioned, at least partially, alongan interior portion of the collection member. In several embodiments,the collection member comprises a sleeve (an elastomeric sleeve).

In other embodiments, the removal member generally divides thecollection member into a first portion and a second portion, such thatthe first portion is situated at a location proximal to the removalmember and the second portion is situated at a location distal to theremoval member. In some embodiments, the first portion is configured togenerally allow biofilm to pass therethrough and the second portion isconfigured to generally prevent biofilm from passing therethrough, suchthat biofilm is collected and trapped within a cavity of the collectionmember as the cleaning device is moved relative to an endotracheal tube.In some embodiments, the first portion comprises a plurality of pores oropenings that are larger in cross-sectional shape than second pores oropenings of the second portion.

According to some embodiments, the removal member is positioned along anexterior surface of the collection member so as to generally divide thecollection member into a first portion and a second portion. The firstportion is situated proximal to the removal member and the secondportion is situated distal to the removal member. In one embodiment, thefirst and second portions form a generally convex, concave or any othershape when the removal member is in a radially expanded position.According to some embodiments, the removal member and the collectionmember are separate items that are permanently or removably attached toeach other. In other embodiments, the removal member and the collectionmember are integrally formed as part of a unitary structure.

According to several embodiments, a cleaning system for clearing debrisfrom an interior wall of a medical tube (e.g., endotracheal tube,catheters, probes, body lumens, arteries, veins, other vasculature,grafts, aspiration conduits, ventilation tubes, etc.) includes anelongated member having a proximal end and a tip along its distal end.In one embodiment, the elongated member comprises one or more lumens orother channels extending within its interior. In some embodiments, thecleaning system additionally comprises a mechanically-expandablescaffold positioned along the elongated member. In one embodiment, thescaffold is adapted to be selectively moved between a radially-collapsedposition and a radially-expanded position. In several embodiments, thescaffold is moved between fully-expanded and fully collapsed radialpositions. In other embodiments, the scaffold is configured to be movedto any partially-expanded or partially-collapsed position that isgenerally between the fully-expanded and fully-collapsed radialpositions. In some embodiments, the scaffold is configured to be movedbetween the radially-collapsed position and the radiallyexpanded-position using one or more self-expanding members, expandingmembers releasably positioned within a sheath, umbrella-type membersand/or the like.

In some embodiments, the scaffold (e.g., mesh scaffold) comprises one ormore removal members (e.g., O-rings, wipers, squeegees, piston rings,etc.) extending outwardly (e.g., radially) from an outer surface of thescaffold. In other embodiments, the removal member is at least partiallypositioned within or through the scaffold. In several embodiments, theremoval member is configured to engage an interior surface of a medicaltube and/or at least a portion of the biofilm situated within themedical tube when the scaffold is in the radially-expanded position. Inanother embodiment, the removal member is configured to contact andremove debris collected on an interior surface of a medical tube whenthe mechanically-expandable scaffold is moved relative to the medicaltube. In yet another embodiment, the scaffold is covered by or otherwisecoupled to an elastomeric sleeve. The cleaning system additionallycomprises an actuation assembly coupled to the proximal end of theelongated member. In some embodiments, the scaffold (e.g., meshscaffold) is configured to move between the radially-collapsed positionand the radially expanded-position by manipulation of the actuationassembly (e.g., trigger, handle, other mechanical actuator, button,other controller, etc.). In some embodiments, expansion and collapse ofthe scaffold occurs mechanically and not hydraulically (e.g., withoutthe use of a balloon or other inflatable member).

In several embodiments, the cleaning system further comprises avisualization element configured for insertion into a lumen of theelongated member for visualizing the interior of the medical tube.

According to some embodiments, the cleaning system comprises acollection member configured to collect at least a portion of removedbiofilm. In one embodiment, the scaffold comprises at least one layer ofmesh. In some embodiments, the scaffold comprises one or more struts,ribs, mechanical bellows and/or other members that are configured to beselectively moved. In some embodiments, the scaffold comprises anumbrella-type structure. In some embodiments, the actuation assembly isconfigured to permit a user to selectively expand or collapse thescaffold in order to modify a pressure exerted by the at least oneremoval member on an inside surface of an endotracheal tube. In severalembodiments, the elongated member comprises an inner shaft and an outershaft, such that movement of the inner shaft relative to the outer shaftcauses the scaffold to move between radially collapsed and expandedpositions.

In some embodiments, the removal member comprises one or more O-rings.In some embodiments, the O-ring has a partial or full circular, oval,X-shaped, rounded, curvate, or irregular shape, or combinations thereof.Other suitable shapes may also be used as desired and/or required. Inone embodiment, the removal member comprises one or more roundedportions or sections. In several embodiments, the removal membercomprises one or more flat, sharp-edged or cornered portions orsections. In yet other embodiments, the removal member comprises bothrounded and flat or cornered portions or sections. In certainembodiments, the removal member comprises one or more wipers. In someembodiments, the removal member comprises one or more squeegees. Inother embodiments, the removal member comprises one or more blades,sharp edges, blades and/or the any other type of edge or surface. Inseveral embodiments, the removal member comprises a helical spring,another type of coiled spring and/or another type of resilient member.In one embodiment, the removal member comprises a spring or otherresilient member that normally moves from a radially-collapsed positionto a radially-expanded position when forces are exerted on it. In otherembodiments, the removal member comprises a spring or other resilientmember that normally moves from a radially-expanded position to aradially-collapsed position when forces are exerted on it. In otherembodiments, the scaffold comprises an expandable spring or anexpandable collet.

According to several embodiments, the cleaning system further includesone or more ports in the elongated member, the actuation assembly and/orany other location. In some embodiments, the port provides access to theinterior lumen of the elongated member. In other embodiments, the tip ofthe elongated member comprises a viewing window, viewing strip, viewingregion, other transparent or translucent region and/or the like. Inother embodiments, the elongated member comprises at least one lumen orother opening to provide access to a location along an exterior of thecleaning device. In one embodiment, the actuation assembly is configuredfor one-handed manipulation of the cleaning system during a cleaningprocedure. In other embodiments, the cleaning device is configured forsingle pass cleaning. In some embodiments, the cleaning system issuitable for use with endotracheal tubes of varying diameters andlengths.

Several embodiments disclosed herein comprise a method of removingdebris from the inside of a conduit. In some embodiments, the conduit isa medical tube. In some embodiments, the conduit is an endotrachealtube. According to some embodiments, methods for removing biofilm froman interior wall of an endotracheal tube or other conduit using thecleaning devices described herein are provided.

In one embodiment, the method comprises providing a non-inflatable,mechanically-actuated cleaning device configured to remove biofilm froman interior wall of an endotracheal tube and/or the vicinity thereof. Inseveral embodiments, the endotracheal tube is inserted into the nativeairway of a patient and coupled to an external ventilator. In someembodiments, the cleaning device is not balloon inflatable. In severalembodiments, the cleaning device comprises an elongate body, a meshscaffold or other type of scaffold, one or more removal members and anactuation assembly. In one embodiment, the elongate body comprises adistal end, a proximal end and a longitudinal axis. In some embodiments,the scaffold is positioned at the distal end of the elongate body. Inone embodiment, the scaffold is positioned at or near a tip of theelongate body. In other embodiments, the scaffold is positioned at anyalong the elongate body. In some embodiments, the removal member iscoupled to the scaffold. In several embodiments, the removal member is aseparate member from the scaffold that is permanently or removablyattached to the scaffold. In other embodiments, the removal member andthe mesh are integrally formed as a unitary structure.

According to several embodiments, the method additionally comprisesdecoupling the endotracheal tube from an external ventilator, insertingthe distal end of the cleaning device into the endotracheal tube whilethe scaffold is in a collapsed position and mechanically actuating themesh scaffold using the actuation assembly to expand the mesh scaffoldfrom the collapsed position to an expanded position, thereby expandingthe removal member to contact the biofilm and/or an inside surface ofthe endotracheal tube. The method further comprises withdrawing thecleaning device from the endotracheal tube while maintaining contactbetween the removal member and the biofilm and/or an interior surface ofthe endotracheal tube in order to dislodge at least a portion ofbiofilm. In some embodiments, the method further comprises collectingsome or all of the dislodged biofilm within the mesh scaffold andremoving the cleaning device from the patient. In several embodiments,the method additionally comprises coupling the endotracheal tube to theexternal ventilator.

According to some embodiments, the removal member of the cleaning deviceused in the biofilm removal method comprises a smooth outer periphery.In some embodiments, the removal member comprises a blunt outer surface.In other embodiments, the removal member comprises a non-smooth and/or anon-blunt outer periphery or surface. In some embodiments, the cleaningdevice comprises two or more removal members. In another embodiment, theremoval member comprises one or more O-rings. In some embodiments, theO-ring has a circular, oval, X-shaped, rounded, curvate, irregularand/or any other shape, or a portion thereof. In another embodiment, theremoval member comprises one or more rounded portions or sections. Inother embodiments, the removal member comprises one or more flat,sharp-edged or cornered portions or sections. In yet other embodiments,the removal member comprises both rounded and flat or cornered portionsor sections. In certain embodiments, the removal member comprises one ormore wipers. In some embodiments, the removal member comprises one ormore squeegees. In other embodiments, the removal member comprises oneor more blades, sharp edges, blades and/or the any other type of edge orsurface. In several embodiments, the removal member comprises a helicalspring, another type of coiled spring and/or another type of resilientmember. In one embodiment, the removal member comprises a spring orother resilient member that normally moves from a radially-collapsedposition to a radially-expanded position when forces are exerted on it.In other embodiments, the removal member comprises a spring or otherresilient member that normally moves from a radially-expanded positionto a radially-collapsed position when forces are exerted on it.

According to some embodiments, the one or more removal members arecoupled to the scaffold using one or more adhesives, stitches, welds,hot melt connections, braided connections, fasteners and/or any otherattachment method or device. In some embodiments, the removal member ispositioned, at least partially, along the outside of the scaffold. Inother embodiments, the removal member is positioned, at least partially,within the interior of the scaffold member and/or through the scaffoldmember. In yet other embodiments, the removal member is routed throughexterior and interior portions or sections of the scaffold. According tosome embodiments, the removal member is positioned along a single planeor generally within a single plane that is generally perpendicular tothe longitudinal axis of the elongate body. In other embodiments, theremoval member comprises a sinusoidal, undulating, curvy, curly and/orwavy shape or design. In some embodiments, the removal member comprisesone or more elastomeric and/or polymeric materials. In otherembodiments, the removal member comprises a metal, an alloy and/or anyother rigid, semi-rigid and/or flexible material.

According to several embodiments, the scaffold of the cleaning device isconfigured to allow airflow through the endotracheal tube while thescaffold is in an expanded position. In some embodiments, the scaffoldof the cleaning device is configured to allow airflow through theendotracheal tube regardless if the scaffold is in a collapsed orexpanded position. In one embodiment, the scaffold of the cleaningdevice comprises mesh, one or more pores, orifices and/or other openingsthrough which air or other fluids can pass. In some embodiments, theactuation assembly of the cleaning device is configured for one-handedmanipulation of the cleaning device during a cleaning procedure. Inother embodiments, the actuation assembly of the cleaning device isconfigured for two-handed manipulation of the cleaning device during acleaning procedure. In one embodiment, the biofilm removal methodcomprises only a single pass of the cleaning device through the interiorof the endotracheal tube to achieve an adequate level of cleaning. Inother embodiments, the cleaning device is configured for repeatedexpansion and collapse of the scaffold and the removal member, therebyallowing the same cleaning device to be used more than once during abiofilm removal method or procedure.

According to several embodiments, the scaffold comprises a porousarchitecture configured to facilitate the collection of biofilm, debrisand/or other materials present within or near the interior of anendotracheal tube. In some embodiments, the scaffold comprises a meshscaffold. In other embodiments, the scaffold comprises a first sectionthat generally permits biofilm to pass therethrough and a second sectionthat generally prevents biofilm from passing therethrough. In oneembodiment, the scaffold of the cleaning device includes an interiorcavity or region into which the removed biofilm and/or other materialsare collected and trapped. In some embodiments, the mesh size, pore sizeor opening size of the first section of the scaffold is generallygreater than that of the second section.

According to some embodiments, the method of removing biofilm from anendotracheal tube additionally includes providing a visualizationelement or device for viewing at least a portion of the interior wall ofthe endotracheal tube, a patient's trachea, tracheobronchial tree and/orany other portion within a patient's anatomy. In one embodiment, thevisualization element comprises an endoscope, a boreoscope, another typeof visualization scope and/or any type of viewing element configured toprovide visual feedback to a clinician during a biofilm removal methodor procedure. In several embodiments, the visualization element isinserted through a lumen of the elongate body. In some embodiments, theelongate body of the cleaning member comprises one, two or more lumensor channels through which a visualization element, another type ofcatheter or scope and/or other devices can be inserted.

In some embodiments, the method of removing biofilm from the inside ofan endotracheal tube additionally comprises aspirating biofilm and/orother materials from an interior of the endotracheal tube using asuction catheter or other aspiration device. In one embodiment,aspiration of biofilm occurs prior to inserting the distal end of thecleaning device into the endotracheal tube. However, in otherembodiments, aspiration of biofilm and/or other materials occurs whilethe cleaning device is being inserted into the endotracheal tube, whilethe endotracheal tube is being removed from the endotracheal tube, afterthe cleaning device has been removed from the endotracheal tube and/orcombinations thereof.

According to several embodiments, the method of removing biofilm from anendotracheal tube further comprises irrigating at least a portion of theinterior wall of the endotracheal tube with a drug, a medicament, atreatment fluid, another type of liquid, gas, other fluid, solid, gel,paste and/or other materials. In some embodiments, irrigation fluidsand/or other materials are adapted to disinfect, decontaminate,sterilize and/or otherwise treat the endotracheal tube. In someembodiments, irrigation fluids and/or other materials are configured toloosen, break up, penetrate, degrade, disperse, dissolve and/orotherwise undermine or affect biofilm deposited on the inside wall orother surface of the endotracheal tube. In some embodiments, irrigationof the interior wall of the endotracheal tube is performed using one ormore irrigation catheters or other devices inserted through a lumen orother channel of the elongate body. In other embodiments, irrigationcomprises delivering a fluid and/or other substances through a catheteror other conduit that is not routed through an interior of the elongatebody or the cleaning device.

In several embodiments, a method of removing biofilm from anendotracheal tube comprises the introduction of one or more diagnosticand/or therapeutic catheters or other instruments within one or morelumens or other channels of elongate body. In some embodiments,catheters or other instruments configured to be positioned through alumen of the elongate body or other portion of the cleaning devicecomprise ultrasonic catheters, radio frequency (RF) catheters,irrigation catheters, aspiration catheters, drug delivery catheters,catheters for delivering light for photodynamic or other light-basedtherapy, other types of catheters or devices, and/or combinationsthereof.

According to some embodiments, a method for cleaning an inside surfaceof an endotracheal tube without removing the endotracheal tube from anative airway of a patient comprises positioning the patient in asemi-upright position, delivering concentrated oxygen oroxygen-containing fluid through the endotracheal tube using a ventilatorfor a predetermined time period and aspirating an interior of theendotracheal tube using an aspiration instrument. In one embodiment,positioning the patient in a semi-upright position comprises elevatingthe head of the bed on which the patient is situated to at leastapproximately 20 to 40 degrees, (e.g., 30 degrees) relative tohorizontal. In some embodiments, the concentrated oxygen oroxygen-containing fluid that is delivered to the patient comprises pureoxygen (e.g., 100% oxygen) or nearly 100% oxygen. In other embodiments,the concentration of oxygen in the fluid delivered through theendotracheal tube is less than 100% oxygen, e.g., 95-100%, 90-95%,80-90%, 70-80% oxygen, air comprising less than 70% oxygen and/or thelike. In some embodiments, the oxygen or oxygen containing fluid isdelivered to the patient for about 10 minutes. In other embodiments,oxygen or oxygen containing fluid is delivered to the patient for lessthan about 10 minutes or longer than about 10 minutes.

In some embodiments, a method for cleaning an inside surface of anendotracheal tube without removing the endotracheal tube from a nativeairway of a patient additionally includes providing an endotracheal tubecleaning device having a radially expandable cleaning member. Accordingto several embodiments, the cleaning member comprises a removal member.In several embodiments, the method additionally comprises determining adeployment depth for the endotracheal tube cleaning device based atleast in part on the length of the endotracheal tube and locking amovable stop on the endotracheal tube cleaning device at an axialposition that causes deployment of the cleaning member at the determineddeployment location. In some embodiments, the method for cleaning anendotracheal tube comprises disconnecting the ventilator from theendotracheal tube.

According to several embodiments, the method for cleaning an insidesurface of an endotracheal tube without removing the endotracheal tubefrom a native airway of a patient additionally comprises inserting thecleaning device into the endotracheal tube according to a determineddeployment depth and mechanically actuating the cleaning member from aradially-collapsed position to a radially-expanded position bymanipulating an actuation assembly of the endotracheal tube cleaningmember. In some embodiments, mechanically actuating the cleaning membercauses the removal member to engage an interior wall of the endotrachealtube and/or a biofilm layer or other debris located along the interiorof the endotracheal tube. In certain embodiments, the methodadditionally includes withdrawing the cleaning device from theendotracheal tube so as to remove biofilm accumulated on the interiorwall of the endotracheal tube. In one embodiment, the methodadditionally includes reconnecting the ventilator to the endotrachealtube after the cleaning device has been withdrawn or otherwise removedfrom the endotracheal tube.

In some embodiments, the removal member of the cleaning device comprisesa smooth outer periphery or surface. In other embodiments, the removalmember comprises a non-smooth outer periphery or surface. In oneembodiment, the removal member comprises one or more O-rings, wipers,squeegees, piston rings, and/or other members. In other embodiments, thecleaning member comprises a mechanically-expandable mesh scaffold.

In other embodiments, a method for cleaning an inside surface of anendotracheal tube without removing the endotracheal tube from a nativeairway of a patient additionally includes providing a visualizationelement for viewing the interior wall of the endotracheal tube. Inseveral embodiments, the method comprises the introduction of one ormore diagnostic and/or therapeutic catheters or other instruments withinone or more lumens or other channels of the cleaning member. In someembodiments, catheters or other instruments configured to be positionedthrough the cleaning member comprise ultrasonic catheters, radiofrequency (RF) catheters, irrigation catheters, aspiration catheters,drug delivery catheters, catheters for delivering light for photodynamicor other light-based therapy, other types of catheters or devices,and/or combinations thereof.

According to some embodiments, a method for removing biofilm from aninterior wall of an endotracheal tube comprises providing anon-inflatable, mechanically-actuated cleaning device configured toremove biofilm from an interior wall of an endotracheal tube. In oneembodiment, the endotracheal tube is inserted into the native airway ofa patient and coupled to an external ventilator. In several embodiments,the method comprises providing a visualization element for viewing theinterior wall of the endotracheal tube. In some embodiments, thecleaning device comprises an elongate body, a scaffold (e.g., meshscaffold), a removal member and an actuation assembly. In severalembodiments, the elongate body comprises a distal end, a proximal endand a longitudinal axis. According to some embodiments, the scaffold ispositioned at the distal end of the elongate body. However, inalternative embodiments, the scaffold is located along any other portionof the elongate body. In some embodiments, the removal member is coupledto the scaffold.

According to some embodiments, the method for removing biofilm from aninterior wall of an endotracheal tube additionally comprises decouplingthe endotracheal tube from the external ventilator, inserting the distalend of the cleaning device into the endotracheal tube while the scaffoldis in a collapsed position, mechanically actuating the scaffold usingthe actuation assembly to expand the scaffold from the collapsedposition to an expanded position, thereby expanding the removal memberto contact the biofilm, and withdrawing the cleaning device from theendotracheal tube while maintaining contact between the removal memberand the biofilm and/or the interior wall of the endotracheal tube todislodge biofilm. In some embodiments, the method further comprisescollecting at least a portion of the dislodged biofilm within thescaffold. In one embodiment, collection of dislodged biofilm comprisesallowing biofilm to pass through a plurality of openings of the scaffoldinto an interior space of the scaffold, and preventing at least aportion of said biofilm from leaving the interior space of the scaffold.The method additionally comprises removing the cleaning device from thepatient

In some embodiments, the method for removing biofilm from an interiorwall of an endotracheal tube additionally comprises coupling theendotracheal tube to the external ventilator. In one embodiment, theremoval member comprises a smooth outer periphery. In alternativeembodiments, the removal member comprises an outer surface or peripherythat is generally blunt. In other embodiments, the removal membercomprises a non-smooth outer periphery or surface. In severalembodiments, the visualization element is provided through a lumen ofthe elongate body of the cleaning device. In one embodiment, the methodadditionally includes viewing the interior wall of the endotracheal tubeduring insertion and/or withdrawal removal of the cleaning device.

According to some embodiments, a method of manufacturing a deviceconfigured to remove biofilm and/or other materials from the interior ofa conduit comprises providing an elongate tube, securing amechanically-expandable scaffold on the elongate tube and mechanicallycoupling the scaffold to an actuation assembly. In some embodiments, thedevice comprises one or more removal members along a periphery or othersurface of the scaffold. The removal members (e.g., O-rings, wipers,squeegees, piston rings, etc.) are configured to engage and removebiofilm and/or other materials collected within an interior wall of theconduit when the scaffold is in a radially expanded position and thedevice is withdrawn from the conduit. In some embodiments, the elongatetube and the removal member comprise one or more polymeric and/orelastomeric materials. In several embodiments, the removal member iscoupled to the scaffold using adhesives, stitches, welds, hot meltconnections, braided connections, fasteners and/or any other attachmentmethod or device.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 illustrates a partial cross-sectional view of an endotrachealtube according to one embodiment.

FIGS. 2A and 2B illustrate perspective and cross-sectional views,respectively, of an embodiment of an endotracheal tube cleaning device.

FIGS. 3A and 3B illustrate partial-sectional views of embodiments of theendotracheal tube cleaning device of FIG. 2A inserted into theendotracheal tube of FIG. 1.

FIG. 3C illustrates a distal end of the endotracheal tube of FIG. 1.

FIGS. 3D and 3E illustrate collapsed and expanded configurations,respectively, of a cleaning member of the endotracheal tube cleaningdevice of FIG. 2A.

FIG. 4 illustrates an embodiment of an endotracheal tube cleaning devicehaving a side port.

FIGS. 5A and 5B illustrate embodiments of a mechanical actuationassembly.

FIG. 6 illustrates a detailed partial cross-sectional view of theendotracheal tube cleaning device of FIG. 2A.

FIG. 7 illustrates an embodiment of a collection member of anendotracheal tube cleaning device.

FIG. 8 illustrates an embodiment of a collection member comprising adouble-layer mesh scaffold.

FIGS. 9A-9D illustrate embodiments of a collection member having aconvex distal section and a concave proximal section.

FIGS. 10A-10H and FIG. 11A illustrate various embodiments of a removalmember of an endotracheal tube cleaning device.

FIG. 11B illustrates one embodiment of a cleaning member having multipleremoval members.

FIG. 12 illustrates another embodiment of an endotracheal tube cleaningdevice having multiple cleaning members.

FIGS. 13A-13C illustrate various embodiments of scraping edges of aremoval member of an endotracheal tube cleaning device.

FIG. 14 illustrates an embodiment of an endotracheal tube cleaningdevice.

FIG. 15A illustrates a “fish-net” embodiment of a cleaning member of anendotracheal tube cleaning device.

FIGS. 15B and 15C illustrate another embodiment of an endotracheal tubecleaning device comprising deployment struts for mechanical expansion ofa cleaning member.

FIGS. 16A-16D illustrate various embodiments of mechanisms formechanical expansion of a cleaning member of an endotracheal tubecleaning device.

FIGS. 17A and 17B illustrate an embodiment of a vented tube assembly.

FIGS. 17C-17E illustrate an embodiment of a mechanically-expandablebellows assembly.

FIGS. 18A-18C illustrate various embodiments of a helical springwireform for mechanical expansion of the cleaning member of anendotracheal tube cleaning device.

FIGS. 19A and 19B illustrate an embodiment of a mechanically-expandablecleaning member (e.g., rolling diaphragm equivalent).

FIG. 20 illustrates a perspective view of an actuation assembly of anendotracheal tube cleaning device.

FIGS. 21A-21D illustrate perspective views of the components of theactuation assembly of FIG. 20.

FIG. 22 illustrates an embodiment of an endotracheal tube cleaningdevice having a movable stop and visible depth markings.

FIGS. 23A-23E illustrate various embodiments of a movable stop.

FIGS. 24A and 24B illustrate two embodiments of an introduction adapter.

FIG. 25 illustrates an endotracheal tube cleaning device inserted withinan endotracheal tube positioned within a native airway of a humanpatient.

FIG. 26 is a flow chart illustrating an embodiment of a process forcleaning an inside surface of an endotracheal tube while a patient issupported by function of the endotracheal tube.

FIG. 27 illustrates an embodiment of a daily extubation process in whichan endotracheal tube cleaning device can be utilized.

FIG. 28 illustrates an embodiment of a process for preventing buildup ofbiofilm within an endotracheal tube.

FIGS. 29A-29D illustrate another embodiment of an endotracheal tubecleaning device having an expansion member and an outer sleeve.

FIGS. 30A-30C illustrate an embodiment of a cleaning device thatcomprises a mesh collection member that is expanded by a spiral spring.

FIGS. 31A and 31B illustrate an embodiment of a cleaning device having ashuttlecock-like collection member.

FIG. 32 illustrates a rotatable thumbwheel actuation assembly.

FIGS. 33A-33D illustrate an embodiment of a scope retention assembly ofan endotracheal tube cleaning device.

FIG. 33E illustrates a cross-sectional view of the actuation assembly ofFIG. 5B.

FIGS. 33F and 33G illustrate the mechanism of retention of the scoperetention assembly.

FIGS. 34A and 34B illustrate a “Slide” embodiment of a scope retentionmember.

FIGS. 35A and 35B illustrate a “Snap” embodiment of a scope retentionmember.

FIG. 36 illustrates the use of an endotracheal tube cleaning device tofacilitate visualization of the conversion from an endotracheal tube toa percutaneous tracheostomy.

DETAILED DESCRIPTION

The discussion and the figures illustrated and referenced hereindescribe various embodiments of a body-inserted tube cleaning system anddevice, as well as methods related thereto. A number of theseembodiments of tube cleaning systems, devices and methods areparticularly well suited to remove biofilm from an interior surface ofan endotracheal tube. However, the various devices, systems, methods andother features of the embodiments disclosed herein may be utilized orapplied to other types of apparatuses, systems, procedures, and/ormethods, whether medically-related or not. For example, the embodimentsdisclosed herein can be utilized for, but are not limited to, cleaningbronchoscopes, chest drainage tubes, gastrostomy drainage tubes,abdominal drainage tubes, other body drainage tubes, feeding tubes,endoscopes, percutaneous dialysis catheters, and any other percutaneousor per os catheters or body-inserted tubes. In addition, as discussed ingreater detail herein, the various embodiments disclosed herein can beused to clean conduits, such as, for example, pipes, tubing, guns, otherbarreled instruments, exhausts and/or other devices with lumens or otherinterior openings. Tubes, lumens and conduits may have a circular,square, rectangular or other cross section.

For example, in one embodiment, the conduit to be cleaned is a gunbarrel, and the cleaning device or system is configured to remove oil,grease, oxidation, rust, mineral deposits, scale, other types ofdeposits, gun powder residue, other types of combustion residue and/orthe like. In other embodiments, the conduit to be cleaned is a pipe,duct, flue (e.g., boiler flue), exhaust conduit or tubing, and thecleaning device or system is configured to remove sludge, mineraldeposits, rust, other oxidation, grease, oil, soot, biofilm, scum, scaleand/or the like.

The materials used for the various components of the endotracheal tubecleaning devices and systems described herein can advantageouslycomprise one or more biocompatible materials.

The term “biofilm” as used herein shall be given its ordinary meaningand shall include, without limitation, biological fluids, solids, gels,deposits, films, debris, and/or secretions, such as mucosal secretions,blood, bacteria, viruses, other microorganisms, protein, feces, urine,albumin and/or any other biological or biologically-related materials.

The term “scaffold” as used herein shall be given its ordinary meaningand shall include, without limitation, support members, collapsiblemembers, expandable members, distensible members, solid structures, meshstructures, braided devices, porous structures, struts, polymericstructures, membranes, mechanically actuated bellows, bladders, stents,umbrella-type devices, ribs, spokes, frames, and the like, andcombinations thereof. Scaffolds may be fully or partially covered or maybe uncovered. Covered scaffolds may comprise skeletons that arepartially or fully covered by membranes, fabrics, films, multiplelayers, and/or coated. Scaffolds may function as the cleaning memberand/or may be used for supporting a cleaning member. Scaffolds can bemechanically actuated, self-actuated, inflated, and/or combinationsthereof.

I. General System

A. Endotracheal Tube

FIG. 1 illustrates an example of an endotracheal tube 100 having aproximal end 102 and a distal end 104. The endotracheal tube 100includes a hollow, central lumen 106 extending through the endotrachealtube 100 from the proximal end 102 to the distal end 104. In someembodiments, the endotracheal tube 100 includes a hole (not shown) atthe tip 108 of its distal end 104 and a hole 110 on a side of theendotracheal tube 100 near the tip 108 of the distal end 104 known as aMurphy eye. In other embodiments, an endotracheal tube can include moreor fewer holes or openings.

With continued reference to the embodiment illustrated in FIG. 1, theendotracheal tube 100 can include one or more balloon cuffs 112 at ornear the distal end 104 of the endotracheal tube 100. The balloon cuff112 is inflated during mechanical ventilation to prevent air leaks backaround the endotracheal tube 100. In some embodiments, the proximal end102 can include a coupling element 114 for connection with a mechanicalventilator. The inner diameter of the endotracheal tube 100 can rangefrom about 1 mm to about 20 mm or from about 5 mm to about 10 mm. Thelength of the endotracheal tube 100 can range from about 10 cm to about40 cm; however, endotracheal tubes of any length can be cleansed by thecleaning devices described herein. The endotracheal tube 100 can bemanufactured to have a slight curve or pre-bend for facilitatinginsertion into a patient's native airway (e.g., trachea).

The endotracheal tube 100 can be configured to be inserted within apatient temporarily or permanently. In some embodiments, theendotracheal tube 100 is inserted within a patient orally or nasally viaan intubation procedure. In other embodiments, the endotracheal tube 100is inserted via a tracheotomy or tracheostomy procedure.

As shown in FIG. 1, biofilm 116 can build up on the interior surface ofthe endotracheal tube 100 over time. If not removed, biofilm 116 canrestrict the airflow through the endotracheal tube 100. In addition,biofilm 116 can harbor harmful bacteria that can eventually lead to thedevelopment of pneumonia and/or other ailments or conditions. The layerof biofilm 116 on the interior surface of the endotracheal tube 100 canbe substantially uniform or can vary substantially in thickness (e.g.,peaks and valleys) along the length of the endotracheal tube 100.

The biofilm 116 can be present anywhere along the interior surface ofthe endotracheal tube 100. In some embodiments, the majority of thebiofilm 116 collects in a main collection region 118 that extends from apoint proximal to the Murphy eye 110 (e.g., about 2.5 cm from the tip108 of the distal end 104) and for approximately another 15 cm towardthe proximal end 102. In some embodiments, approximately 80% of thetotal biofilm found in the endotracheal tube 100 is found within thismain collection region 118. The remaining biofilm can be found from theproximal end of the main collection region 118 to the ventilatorcoupling element 114. The biofilm 116 can have the consistency of rubbercement or nasal secretions. The amount of biofilm 116 present in theendotracheal tube 100 can range anywhere from zero to about thirty cubiccentimeters or more at the time of cleaning, depending on the dimensionsand/or properties of the endotracheal tube, patient conditions orfactors, the length of time within the body before cleaning, and/orother factors. In some embodiments, the internal surface of theendotracheal tube cleaning device 120 can be coated with a bactericidebefore insertion within a patient to help prevent or reduce thelikelihood of bacterial growth within the biofilm 116.

B. Endotracheal Tube Cleaning Device

FIG. 2A illustrates an embodiment of an endotracheal tube cleaningdevice 120. As shown, the endotracheal tube cleaning device 120 caninclude an elongate body 122, an actuation assembly 124 at the proximalend of the elongate body 122, and a cleaning member 126 generally at thedistal end of the elongate body 122. In other embodiments, the cleaningmember 126 is positioned anywhere along the length of the elongate body122 (e.g., near the proximal end of the elongate body, generally betweenthe distal and proximal ends of the elongate body, etc.). In someembodiments, the actuation assembly 124 is a syringe-like mechanism thatactuates expansion, or deployment, of the cleaning member 126. Theactuation assembly 124 can be configured to provide single actiondeployment of the cleaning member 126. As discussed in greater detailherein, the cleaning member 126 can be configured to remove and collector trap some or all of the biofilm 116 lining the endotracheal tube 100.

The endotracheal tube cleaning device 120 can be sized, shaped, orotherwise adapted so as to be inserted within any commercially availableendotracheal tube (e.g., the endotracheal tube 100) or otherbody-inserted tube for cleaning. In some embodiments, the endotrachealtube cleaning device 120 can be sized, shaped, or otherwise adapted soas to be inserted within a specially-designed, proprietary endotrachealtube. In some embodiments, the outside diameter of the elongate body 122of the endotracheal tube cleaning device 120 ranges from about 0.05 mmto about 10 mm, e.g., from about 1 mm to about 5 mm, about 2 mm to about4.5 mm, about 2.5 mm to about 3.5 mm, about 5 mm to about 8 mm, about 8mm to about 10 mm, or greater, and overlapping ranges thereof. Thelength of the elongate body 122 distal to the actuation assembly 124 canrange from about 10 cm to about 70 cm, or greater, e.g., from about 10cm to about 20 cm, about 20 cm to about 30 cm, about 30 cm to about 40cm, about 40 cm to about 50 cm, about 50 cm to about 70 cm, andoverlapping ranges thereof. In one embodiment, the length of theelongate body is about 29 cm to about 45 cm. The dimensions can beadjusted to accommodate various uses or various body-inserted tubeswithout departing from the spirit and/or scope of the disclosure.

In some embodiments, the endotracheal tube cleaning device 120 ismanufactured with a slight curve to match or substantially conform tothe curve of commercially available endotracheal tubes. The curvature ofthe endotracheal tube cleaning device 120 can advantageously reduce thefriction between the outer surface of the endotracheal tube cleaningdevice 120 and the inner surface of the endotracheal tube 100 and canavoid disruption of the biofilm 116 during insertion of the endotrachealtube cleaning device 120. The curvature of the endotracheal tubecleaning device 120 can range from about a 5 cm to a 50 cm radius orfrom about a 10 cm to about a 30 cm radius. In one embodiment, theradius of the curvature of the endotracheal tube cleaning device 120 isapproximately 17.5 cm. However, in other embodiments, the radius ofcurvature of the endotracheal tube cleaning device 120 can be greater orsmaller than disclosed herein without departing from the spirit and/orscope of the disclosure. The endotracheal tube 100 can comprise an Sshape or other curved shape upon insertion into a patient airway. Insome embodiments, the endotracheal tube cleaning device 120 is generallystraight in order to facilitate efficient insertion.

FIG. 2B illustrates a cross-sectional view of the distal end of theendotracheal tube cleaning device 120. The elongate body 122 of theendotracheal tube cleaning device 120 includes an inner shaft or sheath128 and an outer shaft or sheath 129. In some embodiments, the innershaft 128 and the outer shaft 129 connect the actuation assembly 124(not shown) to the cleaning member 126. The inner shaft 128 is coupledto the distal end of the cleaning member 126 and is configured totransmit the motive force necessary to expand the cleaning member 126 bycompressing the distal end of the cleaning member 126. The outer shaft129 is coupled to the proximal end of the cleaning member 126 and holdsthe proximal end of the cleaning member 126 in place while the distalend is compressed or deployed. In this manner, the cleaning member 126can be selectively expanded radially so as to impart a radial forceagainst the inside wall of the endotracheal tube 100 and/or biofilmcollected thereon. This and other embodiments of the expansion mechanismof the cleaning member 126 will be described in further detail below.

C. Endotracheal Tube Cleaning System and General Operation

FIGS. 3A and 3B illustrate partial-sectional views of embodiments of theendotracheal tube cleaning device 120 inserted into the endotrachealtube 100. In some embodiments, the endotracheal tube 100 is disconnectedfrom a ventilator and a distal tip 130 of the endotracheal tube cleaningdevice 120 is inserted through the ventilator coupling member 114. Thedistal tip 130 of the cleaning device 120 can be advanced until thedistal tip 130 is positioned within, or just distal of, the Murphy eye110. In other embodiments, the ventilator coupling member 114 is removedbefore insertion of the endotracheal tube cleaning device 120.

As shown in FIGS. 3A and 3B, the cleaning member 126 can include aremoval member 132 and a collection member 134. In some embodiments, thecleaning member includes more than one removal member and/or more thanone collection member. The removal member 132 can be configured tocontact or engage the inside wall of the endotracheal tube 100 uponradial expansion of the cleaning member 126. With reference to FIG. 3C,the removal member 132 can be positioned within a region 135 justproximal of the Murphy eye 110 (e.g., within about 0.5 cm to about 2cm). However, the removal member 132 can be positioned at any positionwithin the endotracheal tube 100 depending upon a determination of wherethe biofilm accumulation begins (e.g., via the visualization meansdescribed herein) and/or any other factor. Mechanisms for controllingthe depth of insertion will be further described below.

In some embodiments, the conduit 100 to be cleaned is a gun barrel, andthe cleaning device 120 or system comprises one or more removal members132 that are configured to remove oil, grease, oxidation, rust, mineraldeposits, scale, other types of deposits, gun powder residue, othertypes of combustion residue and/or the like. In other embodiments, theconduit 100 to be cleaned is a pipe, duct, flue (e.g., boiler flue),exhaust conduit or tubing, and the cleaning device 120 or systemcomprises one or more removal members 132 that are configured to removesludge, mineral deposits, rust, other oxidation, grease, oil, soot,biofilm, scum, scale and/or the like.

After proper positioning of the endotracheal tube cleaning device 120within the endotracheal tube 100, the cleaning member 126 is expanded bythe actuation assembly 124 such that the removal member 132 contacts theinside wall of the endotracheal tube 100 and/or the biofilm layersituated thereon. FIGS. 3D and 3E illustrate the collapsed and expandedconfigurations, respectively, of the cleaning member 126. Afterexpansion of the cleaning member 126 by the actuation assembly 124, theendotracheal tube cleaning device 120 can be withdrawn from theendotracheal tube 100 by a clinician. As the endotracheal tube cleaningdevice 120 is withdrawn from the interior of the endotracheal tube 100,the removal member 132 removes biofilm 116 from the inside of theendotracheal tube 100, and the collection member 134 advantageouslytraps and collects the removed biofilm. Upon completion of a cleaningprocedure or as otherwise desired, the clinician can manipulate theactuation assembly of the cleaning device to return the cleaning member126 to its collapsed configuration. Additional details regarding theexpansion and collapse of the cleaning member, as well as the manner inwhich the collection member traps and collects removed biofilm, areprovided below.

D. Side Port

FIG. 4 illustrates an embodiment of an endotracheal tube cleaning device120 having a side port 140 coupled to the proximal end of theendotracheal tube cleaning device 120. As shown in the embodiment ofFIG. 4, the side port 140 branches off from the main body of theactuation assembly 124. The side port 140 can branch off of at anylocation along generally the proximal end of the endotracheal tubecleaning device 120. For example, in other embodiments, the side port140 can branch off of the elongate body 122 at a location distal to theactuation assembly 124.

The side port 140 can be constructed without sharp edges and corners toenhance safety and/or to provide one or more other benefits. The lengthof the side port 140 can be sufficiently long so as to preventcontamination of the scopes, probes, catheters, and/or other instrumentsinserted therein due to contact or exposure to the endotracheal tube 100or the biofilm 116 removed from the endotracheal tube 100. The length ofthe side port 140 can be just a few inches to avoid patient contact oras much as ten feet to avoid proximity to the patient. In someembodiments, the length of the side port 140 ranges from about 0.5inches to about 24 inches.

In some embodiments, the side port 140 includes an elastomeric diaphragmto reduce or eliminate airflow bypass. The elastomeric diaphragm canhave a slit, valve, or flap to allow insertion of scopes, catheters,and/or other instruments. The elastomeric diaphragm can comprise anysuitable material, such as, for example, latex, silicone, urethane,other elastomeric or polymeric materials and/or the like. The thicknessof the diaphragm can range from about 0.001 inches to about 0.1 inchesor from about 0.005 inches to about 0.020 inches.

As shown, the side port 140 can be used for the introduction of avisualization scope 142. In some embodiments, the visualization scope142 comprises an endoscope or boreoscope. However, the visualizationscope 142 can include any other scope or viewing element configured toprovide visual feedback to the clinician or other user of the cleaningdevice. The visualization scope 142 can include one or more lightdelivery elements (e.g., light fibers) and an imaging or visualizationelement (e.g., an ultrasound probe, a fiber optic camera, a CCD camera,optical imaging fibers, etc.), thereby providing a clinician withsimultaneous illumination and viewing of selected portions within theendotracheal tube 100, such as, for example, the biofilm 116 along theendotracheal tube walls, possible tube obstructions, and/or the like.Accordingly, such a visualization scope or similar tools can assist inthe proper placement of the endotracheal tube cleaning device 120 withinthe endotracheal tube 100.

In some embodiments, the visualization scope 142 includes a bundle offiber optic cables, with at least some of the fibers configured toprovide light and at least some of the fibers configured to provideviewing capabilities. In some embodiments, the light fibers can extendaround the periphery of the visualization scope 142 (e.g., along theinner wall) and the viewing fibers can extend through the centralportion of the visualization scope 142. In some embodiments, the lightfibers are coupled to a light source and the viewing fibers are coupledto a direct camera connection and/or to an optical connector. Thevisualization scope 142 can advantageously provide the clinician with anassurance that the endotracheal tube cleaning device 120 is placedproperly and does not unintentionally disrupt the biofilm. In someembodiments, the visualization scope 142 is configured to extend beyondthe distal end 104 of the endotracheal tube 100.

The visualization scope 142 can include an integral or removable sheath,sleeve, or jacket that extends along all or a portion of its length andthat is configured to prevent against contamination and to allowrelatively easy reuse of the visualization scope 142 for multiplepatients and/or procedures. In some embodiments, the visualization scope142 and/or its sheath is pre-curved to assist in positioning thevisualization scope 142 within the endotracheal tube cleaning device120.

In some embodiments, the visualization scope 142 and/or its sheathincludes a stopper (fixed or adjustable) that is configured to helpposition the distal tip of the visualization scope 142 at apredetermined or adjustable position within the endotracheal tubecleaning device 120 (e.g., in a viewing window at the distal tip 130 ofthe endotracheal tube cleaning device). The stopper can be configured toabut against the proximal end of the side port 140. The side port 140can have visible markings that correspond to markings on thevisualization scope 142 to aid in the positioning of the distal end ofthe visualization scope 142 and/or to aid in the application of thestopper. The visible markings or indicia can comprise lines, numbers,and/or text labels.

The thickness of the sheath of the visualization scope 142 can rangefrom about 0.05 mm to about 0.5 mm, such as, for example, about 0.1 mm.The outer diameter of the visualization scope 142 can range from about0.5 mm to about 2 mm, depending on the size of a lumen or channel of theendotracheal tube cleaning device 120, as described in further detailbelow.

As schematically illustrated in FIG. 4, the visualization scope 142 canbe coupled to a visualization unit 144 (e.g., via a coupling element ofa camera head). In some embodiments, the visualization unit 144 includesa light source for delivery of light to the endotracheal tube, theendotracheal tube cleaning device, and/or the patient's native airwayvia light delivery elements. The light delivery elements can provideillumination, activation of drugs delivered within the endotracheal tube(e.g., in conjunction with photodynamic therapy) and/or othercapabilities. In other embodiments, the visualization unit 144 includesa display 146 for enhanced viewing. For example, the display 146 caninclude a monitor capable of displaying high-quality, high-resolutionimages. In other embodiments, the visualization unit 144 can include oneor more other types of output devices. Moreover, the visualization unit144 can be configured to store in memory (temporarily and/orpermanently) images obtained by a scope during a cleaning procedure. Insome embodiments, the visualization unit 144 can transmit the imagesover a network (wired or wireless) to remote storage, display, and/orprocessing devices. These embodiments advantageously enable asupervising physician to observe and monitor the cleaning procedure anddirect further intervention or treatments from a remote location (forexample, outside the ICU). In some embodiments, the visualization scope142 or other visualization member or element can be coupled to thevisualization unit 144 via an optical connection and not an RFconnection. In such configurations, the images captured by thevisualization scope 142 can be optically coupled to the monitor and arenot transmitted by RF communication devices or methods. In accordancewith some embodiments of the visualization system, the percent occlusionof the endotracheal tube caused by deposited biofilm can be calculatedor determined by a processor coupled to the monitor based at least inpart on the images captured by the visualization member. In someembodiments, the calculated percentages can be displayed on the monitorin real-time as the visualization member (e.g., scope) is advancedwithin the endotracheal tube. In some embodiments, a visual indication(such as colored indicia) is displayed to indicate the need to clear anendotracheal tube clogged with biofilm. For example, green, yellow andred colored indicia can be displayed on the monitor to indicate variouslevels of conditions.

In other embodiments, the side port 140 can be used for the introductionof diagnostic and/or therapeutic catheters or other instruments. Examplecatheters include, but are not limited to, ultrasonic catheters, radiofrequency (RF) catheters, irrigation catheters, aspiration catheters,drug delivery catheters, catheters for delivering light for photodynamicor other light-based therapy, and/or the like. In yet other embodiments,diagnostic and/or therapeutic catheters can be introduced in conjunctionwith the endotracheal tube cleaning methods, procedures, and/or devicesdescribed herein but are not inserted within the endotracheal tubecleaning device 120 itself. Visualization and other facilitative and/orsupplementary modalities will be described in further detail below.

II. Structural Components and Connection Interfaces

A. Actuation Assembly

FIG. 5A illustrates the proximal end of the endotracheal tube 100 and anembodiment of an endotracheal tube cleaning device 120 situated therein.As shown in FIG. 5A, the actuation assembly 124 can include a handle 150and a trigger 152. FIGS. 5A and 5B illustrate two embodiments of theactuation assembly 124. The actuation assembly 124 can comprise aone-part assembly or a multi-part assembly (e.g., two, three or moreparts). The distal end of the handle 150 can be coupled to the outershaft 129 of the endotracheal tube cleaning device 120 using anymechanical fastener, adhesive, and/or other coupling device or method,including, for example, interference fits, ultrasonic welding, UV cureadhesives, epoxy, and/or the like. In the depicted embodiment, theproximal end of the handle 150 includes a grip 153 that is sized,shaped, or otherwise adapted to receive an operator's thumb or otherfinger. The grip 153 can be formed in line with the longitudinal axis ofthe elongate body 122 (as shown in FIG. 5A) or can be offset withrespect to the longitudinal axis of the elongate body (as shown in FIG.5B). In some embodiments, the distal end of the handle 150 is integralwith the outer shaft 129.

The distal end of the trigger 152 can be coupled to the inner shaft 128using any mechanical fastener, adhesives, and/or other coupling deviceor method, including, for example, interference fits, ultrasonicwelding, UV cure adhesives, epoxy, and/or the like. In some embodiments,the distal end of the trigger 152 is integral with the inner shaft 128.In the illustrated embodiment, the proximal end of the trigger 152includes two grips 154, 155 that may be symmetrically positioned aboutthe longitudinal axis of the handle 150. Each of the two grips 154, 155can be sized, shaped, or otherwise adapted to receive an operator'sfinger. The grips 153, 154, 155 can comprise fully-closed grips (e.g.,circular grips as shown in FIGS. 5A and 5B) or non-closed grips (e.g.,substantially semi-circular grips as shown in FIG. 5B). As shown in FIG.5B, the handle thumb loop 153 is more natural or ergonomic to grip withthe thumb, the finger grips 154, 155 are easier to access, and thetrumpet-like, or flared, opening on the proximal end of the handle 150prevents or reduces the possibility of kinking.

Materials for the handle 150 and trigger 152 can include any suitablematerials, such as, for example, acrylonitrile-butadiene-styrene (ABS),polycarbonate, K-RESIN, other polymeric or elastomeric resins (e.g.,rigid or semi-rigid resins, generally stiff resins, etc.) and/or thelike. In some embodiments, the materials are tough, non-brittle,injection-moldable, plastic resins. In other embodiments, the materialsinclude one or more modifiers to improve stiffness and/or other physicalproperties so that actuation of the trigger 152 and/or otherfunctionality of the endotracheal tube cleaning device 120 is notcompromised. The modifiers can include glass fiber, calcium carbonate,titanium oxide, carbon, combinations of the same, and/or the like. Insome embodiments, the handle 150 and the trigger 152 include internalribs to improve stiffness.

The actuation assembly 124 advantageously allows for single person,single-handed operation of the endotracheal tube cleaning device 120.The trigger 152 is shown in a position that keeps the cleaning member126 in a collapsed configuration (see FIG. 3D). In order to actuate theendotracheal tube cleaning device 120 so that the cleaning member 126transitions from the collapsed configuration into a desired deployedconfiguration (see FIG. 3E), manual force can be applied to the trigger152 and handle 150 to move the trigger 152 proximally with respect tothe handle 150 (shown in phantom). As the trigger 152 moves with respectto the handle 150, the inner shaft 128 and the outer shaft 129 aredriven to move relative to one another. Accordingly, the relativemovement of the inner and outer shafts 128, 129 can apply compressiveand tensile forces to the cleaning member 126 to selectively expand andcollapse, respectively, the cleaning member 126. As discussed in greaterdetail below, the extent of expansion of the cleaning member 126 can beadvantageously controlled by the actuation member 124. In someembodiments, the actuation assembly 124 enables single-hand operationand/or single action deployment of the cleaning member 126.

B. Main Elongate Body

FIG. 6 illustrates a detailed cross-sectional view of the distal andproximal ends of the endotracheal tube cleaning device 120. As describedabove, the main elongate body 122 of the endotracheal tube cleaningdevice 120 can include an inner shaft 128 and an outer shaft 129.

1. Outer Shaft

In some embodiments, the outer shaft 129 of the main elongate body 122extends from the handle 150 of the actuation assembly 124 to theproximal end of the cleaning member 126. As shown in FIG. 6, theproximal end of the outer shaft 129 can be assembled into an openinglocated at the distal end of the handle 150. As described above, theouter shaft 129 can be coupled to the handle 150 by any suitablemechanical and/or adhesive method or device, such as interference fits,mechanical fasteners, ultrasonic welding, UV cure adhesives, epoxy,and/or the like. The distal end of the outer sheath 129 can be coupledto the proximal end of the cleaning member 126 by any suitableattachment method or device, including, but not limited to, adhesives,crush ribs, heat shrink tubing, other low-profile mechanical fasteners,other attachment methods or devices, ultrasonic bonding, interferencefits, and/or the like.

With continued reference to the embodiment illustrated in FIG. 6, theouter shaft 129 comprises a central lumen or channel in which the innershaft 128 is slidably retained. In some embodiments, the cross-sectionof the outer shaft 129 can be circular, substantially circular,elliptical, oval and/or any other shape. In some embodiments, the outerdiameter of the outer shaft 129 ranges from about 1.5 mm to about 4 mm;however the outer diameter of the outer shaft 129 can be smaller than1.5 mm or larger than 4 mm, as desired and/or required. In someembodiments, the outer shaft 129 is an extrusion comprising polyolefinand/or one or more other plastic materials, such as, for example,polypropylene, PEPAX, polyester, nylon, polyimide, polyethyleneterephthalate (PET), polyethylene terephthalate glycol (PETG), and/orthe like.

2. Inner Shaft

In some embodiments, the inner shaft 128 is located within an innerlumen of the outer shaft 129 and is configured to move with respect tothe outer shaft 129 in a direction along the longitudinal axis of theouter shaft 129. In some embodiments, the inner shaft 128 extends fromthe trigger 152 to the distal tip 130 of the endotracheal tube cleaningdevice 120. The inner shaft 128 can be coupled to the distal tip 130 byany suitable attachment method or device, such as, for example,adhesives, crush ribs, heat shrink tubing, mechanical fasteners, othermechanical devices or methods, low-profile mechanical connection means,ultrasonic bonding, interference fits, and/or the like. As shown, theinner shaft 128 can be coupled to the distal tip 130 and to the cleaningmember 126 with heat shrink tubing 160. In other embodiments, the innershaft 128 and the distal tip 130 are integrally formed as a singlemolded component.

In some embodiments, the inner shaft 128 is a hollow sheath or tube. Insome embodiments, the outer diameter of the inner shaft 128 is less than4 mm and the inner diameter of the inner shaft 128 is greater than 1 mm;however, the inner shaft 128 can have any other diameter, as desiredand/or required. For example, the outer diameter of the inner shaft 128can range from about 0.85 mm to about 2.5 mm and the inner diameter ofthe inner shaft 128 can range from about 0.5 mm to about 2 mm. The innershaft 128 can include a central lumen or channel 162 for theintroduction of a visualization scope and/or one or more diagnostic ortherapeutic catheters or other instruments. In some embodiments, avisualization element (e.g., fiber optic camera) of a visualizationscope (e.g., visualization scope 142) can be inserted into the centrallumen or channel 162. The central lumen or channel 162 can have adiameter ranging from about 0.5 mm to about 1.5 mm (e.g., about 1 mm).However, the diameter of the central lumen or channel 162 can be smallerthan 0.5 mm or larger than 1.5 mm as desired and/or required by thedimensions of the inner shaft 128. A depth stop 166 can be included toposition a visualization scope for desired or required opticalcharacteristics, thereby resulting in maximum viewing potential.

In other embodiments, the inner shaft 128 includes one or more internaland/or external channels adapted to selectively receive scopes and/orother instruments or devices for visualization and/or any other purpose.For example, the one or more channels can be used for light delivery,photodynamic therapy, fluid delivery (e.g., air, therapeutic agents,saline), irrigation, aspiration, and/or the like. In some embodiments,the one or more channels can comprise an equilibrium channel to reduceor alleviate the any negative pressure or suction effect created distalto the expandable cleaning member as the endotracheal tube cleaningdevice 120 is being withdrawn from the endotracheal tube 100. Thechannels can extend through any length of the inner shaft. For example,one or more channels can extend from generally the proximal end togenerally the distal end of the endotracheal tube cleaning device 120.In some embodiments, the one or more channels can include an inlet incommunication with the side port 140 and one or more outlets in thedistal tip 130, in or adjacent to the removal member 132, in the sidewall of the endotracheal tube cleaning device 120. In other embodiments,the one or more channels can include inlets or outlets at otherlocations of the endotracheal tube cleaning device 120.

In other embodiments, the inner shaft 128 is a solid, central rod. Theinner shaft 128 can have a circular, substantially circular, elliptical,oval, and/or any other cross-sectional shape. In some embodiments, theinner shaft 128 comprises an extrusion having polyolefin and/or otherplastic materials, such as, for example, polypropylene, PEPAX, polyetherether ketone (PEEK), polyester, nylon, polyimide, polyethyleneterephthalate (PET), polyethylene terephthalate glycol (PETG), and/orthe like.

3. Distal Tip

In some embodiments, the distal tip 130 is a closed tip to preventagainst exposure of the internal structure of the endotracheal tubecleaning device 120, and any instruments or devices inserted therein, tothe biofilm 116 or other potential contaminants within the patient'sbody. The distal tip 130 of the endotracheal tube cleaning device 120can comprise one or more injection-moldable plastics, polymeric resins,including, but not limited to, polycarbonate, PET, PETG, nylon,polypropylene, K-RESIN, and/or the like. In some embodiments, at least aportion of the distal tip 130 can comprise a clear, transparent orsemi-transparent material to form a viewing “window.” According to someembodiments, the window comprises a thickness of less than about 0.010inches (for example, about 0.001 inches to about 0.002 inches, about0.003 inches to about 0.004 inches, about 0.005 inches to about 0.006inches, about 0.007 inches to about 0.008 inches, about 0.009 inches toabout 0.010 inches, and overlapping ranges thereof). The injection moldof the distal tip 130 can be polished (e.g., using an SPE/SPI A1 “highpolish” finish of the injection mold) such that at least the distal endof the distal tip 130 is optically transparent or partially opticallytransparent. In some embodiments, the transparent material can beconfigured to enable a “fish eye” view for enhanced viewing of theendotracheal tube 100 itself, any biofilm that could be accumulating inthe tube, and/or the like. Magnifying capabilities may also be included.

In some embodiments, the viewing window can have optical properties toprovide magnification and/or angular correction to correct for thenatural tendency for the device to follow the outer bend of theendotracheal tube. For example, the optical properties can enable thescope to provide a view of the lumen in the middle of the endotrachealtube and not a view of the side of the visualization scope or thebiofilm itself. The viewing window can also comprise a filter, coating,layer and/or other mechanism to reduce glare of flashback from a lightdelivery element (e.g., an endoscope light). In some embodiments, theviewing window comprises one or more anti-reflective coatings, includingbut not limited to magnesium fluoride and oxides, such as siliconeoxide, titanium oxide, zirconium oxide. One or more of these (or other)coatings or layers can be applied to one and/or both sides of thewindow. In some embodiments, the viewing window comprises a hydrophobicmaterial. In several embodiments, the viewing window is scratchresistant and/or comprises a slick surface that repels biofilm andsmudges. In some embodiments, the window includes a convex or angledshape with a refractive index that reduces or limits glare.

In some embodiments, the distal end of the distal tip 130 is sized,shaped, and/or otherwise adapted to facilitate introduction into, orpenetration of, the biofilm 116 without dislodging the biofilm 116. Forexample, the distal end of the distal tip 130 can have a radius fromabout 0.005R to about 0.050R, or from about 1 mm to about 15 mm. Thedistal tip 130 can be radiused using a radio frequency tool, byinjection molding and/or any other suitable forming technologies. Inarrangements wherein a visualization scope is to be used in conjunctionwith the endotracheal tube cleaning device 120, the optically cleardistal end of the distal tip 130 can be relatively thin (for example,from about 0.010 inches to about 0.20 inches thick) to improve theoptical qualities of the distal tip 130 for enhanced visualization. Inother embodiments, the optical properties of the clear, transparent orsemi-transparent materials used to form the distal tip 130 (e.g., anextrudable grade of clear polypropylene) may help reduce or eliminatethe need of the relatively thin tip. In some embodiments, the inside ofthe distal tip 130 at the junction of the window includes a radius ofabout 0.005R to 0.015R to facilitate and improve injection molding andultimately optical clarity without imperfections.

In some embodiments, the distal tip 130 can include one or more outletsor ports (not shown) to provide access to the interior of theendotracheal tube and/or to the patient's airway (e.g., thetracheobronchial tree) through the endotracheal tube cleaning device120. Such outlets can provide openings for airflow through theendotracheal tube cleaning device 120. For example, an outlet can be incommunication with an inner lumen or channel of the endotracheal tubecleaning device 120 into which diagnostic and/or therapeutic instruments(e.g., aspiration, irrigation, and/or drug delivery mechanisms) can beinserted. In some embodiments, the one or more outlets can permit theescape of a fluid, such as air or therapeutic agents, from theendotracheal tube cleaning device 120. In other embodiments, the one ormore outlets can permit the escape of a catheter or conduit insertedthrough an internal channel of the endotracheal tube cleaning device120. The outlet can include a diaphragm, slit, one-way valve and/or thelike to substantially seal off the inner lumen or channel, therebypreventing or reducing the likelihood of contamination of the interiorof the endotracheal tube cleaning device 120 and/or the therapeuticand/or diagnostic instruments inserted therein. In some embodiments, thedistal end allows for airflow across the cleaning device. In oneembodiment, the distal end of the cleaning device is configured for theintroduction of anti-bacterial agents, bactericides, antiviral agents,mucolytic agents, saline solution, sterilant, enzymatic cleaner,germicide, antimicrobial fluid, detergents, combinations thereof and/orany other fluid or material.

C. Cleaning Member

With continued reference to FIG. 6, an embodiment of the cleaning member126 is illustrated. As described above, the cleaning member 126 caninclude a removal member 132 and a collection member 134. In someembodiments, the removal member 132 and the collection member 134 can betwo separate members. In other embodiments, a single, integralremoval/collection member can perform removal and collection ofaccumulated biofilm. In yet other embodiments, the cleaning member 126may not include a removal member 132 (e.g., an O-ring, wiper, etc), asdepicted in the embodiments illustrated in FIGS. 2A and 2B, for example.In some embodiments, the cleaning member 126 comprises a distensiblescaffold that removes and collects the deposited biofilm. In someembodiments, the cleaning member 126 comprises a distensible meshscaffold covered by an expandable (e.g., elastomeric) sleeve.

According to some embodiments, the removal member 132 and/or any otherportion of the cleaning member is configured to be actively mechanicallyactuated between an expanded configuration and a collapsedconfiguration. In several embodiments, the removal member 132 and/or anyother portion of the cleaning member 134 are actively mechanicallyactuated without the use of a sheath, sleeve, covering and/or the like.In another embodiment, the removal member and/or any other portion ofthe cleaning member are non-bristled and/or non-sheathed.

In some embodiments, the removal member 132 and/or the collection member134 of the cleaning member 126 can elute and/or be coated with a fluid,drug, therapeutic agent, and/or other medicament or substance that isconfigured to clean, disinfect, decontaminate, sterilize, and/or preventfuture contamination of the endotracheal tube 100 and/or to degrade,disperse, and/or dissolve biofilm deposited along the interior surfaceof the endotracheal tube. Such materials can include, for example, ananti-bacterial agent, a mucolytic agent, a saline solution, a sterilant,an enzymatic cleaner, a germicide, and antiviral drug, an antimicrobialdrug, and/or a detergent. A coated removal member and/or collectionmember can be configured to deliver the fluid, drug, therapeutic agent,and/or other materials upon contact with the inside wall of theendotracheal tube 100. A coating of the cleaning member 136 can alsocomprise one or more absorbent materials, such as, for example,super-absorbent polymers (e.g., polyacrylimide and/or the like).

1. Collection Member

As described above, the collection member 134 can be adapted to collectand/or trap biofilm removed by the removal member 132. In someembodiments, the collection member 134 effectuates expansion of theremoval member 132 as it is expanded by the relative movement betweenthe inner and outer shafts 128, 129. However, any other method ofselectively expanding and contracting the removal member 132 can beused. The collection member 134 can advantageously be constructed toallow sufficient airflow through the endotracheal tube 100 during use.For example, the air flow rates can range from about 0.08 liter perminute to about 10 liters per minute, from about 1 liter per minute toabout 5 liters per minute or from about 0.1 liter per minute to about 1liter per minute.

In some embodiments, the collection member 134 comprises a distensiblescaffold that can be mechanically actuated (e.g., actively mechanicallyactuated) between an expanded configuration and a collapsedconfiguration. In some embodiments, the scaffold comprises a mesh orbraided scaffold (see FIG. 6). In several embodiments, the scaffold isnon-sheathed and/or non-bristled. The scaffold can comprise a woventubular braided material. The fibers of the braid can range in diameter(or other cross-sectional dimension) from about 0.001 inches to about0.04 inches, or greater, e.g., about 0.001 inches to about 0.005 inches,about 0.005 inches to about 0.010, about 0.010 inches to about 0.020inches, and overlapping ranges thereof. However, the diameter or othercross-sectional dimension of the fibers can be smaller than 0.001 inchesor greater than 0.040 inches, as desired or required. The braidedmaterial can be comprised of PET, nylon, polyester, polypropylene andother extrudable plastic resins that are flexible in the extruded state.The pick count (e.g., which in some embodiments is the number of fibersor picks crossing per inch) of the braided material can range from 5 to25 picks per inch, or greater, e.g., from about 5 to 8 picks per inch,about 8 to 12 picks per inch, about 12 to 14 picks per inch, about 14 to16 picks per inch, about 16 to 18 picks per inch, about 18 to 20 picksper inch, about 20 to 25 picks per inch, and overlapping ranges thereof.

According to some embodiments, the scaffold, the collection memberand/or any other portion of the cleaning device is configured to beactively mechanically actuated between an expanded configuration and acollapsed configuration. In several embodiments, the scaffold, thecollection member and/or any other portion of the cleaning device areactively mechanically actuated without the use of a sheath, sleeve,covering and/or the like. In another embodiment, the scaffold, thecollection member and/or any other portion of the cleaning device arenon-bristled and/or non-sheathed.

In other embodiments, the collection member 134 is a scaffold comprisinga porous elastomeric polymer material, such as silicone, urethane,and/or latex, or a porous foam material. FIG. 7 illustrates anembodiment of the collection member 134 comprising a porous elastomericpolymer material.

In some embodiments, the collection member 134 has a generally uniformconstruction from one end to the other end. In other embodiments, thecollection member 134 can have varying constructions for differentportions of the collection member 134 to serve different purposes. Forexample, a distal section of the collection member 134 can have aconstruction just large enough to allow air flow (e.g., high pick count,fine weave, small pore size, etc.), which advantageously results in theefficient trapping and storage of biofilm 116, and the proximal sectionof the collection member 134 can have a construction with largeropenings (e.g., low pick count, loose weave, large pore size, etc.) tofacilitate collection of the biofilm 116 while still allowing expansionof the removal member 132. FIGS. 9A-9D, which are described below,illustrate embodiments of collection members having proximal and distalsections of varying porosity. In some embodiments, the pick count of thedistal section of the collection member 134 can range from about 10 toabout 25 picks per inch and the pick count for the proximal section canrange from about 5 to about 10 picks per inch. In some embodiments, thedistal section can have a construction that is impermeable orsubstantially impermeable to fluids or permeable so as to allow fluidsto filter through while catching solid and semi-solid debris.

In some embodiments, the collection member 134 comprises two or morelayers of braided or mesh material. The two or more layers can havevarying pore size or pick count constructions. For example, FIG. 8illustrates an embodiment of the collection member 134 comprising adouble-layer mesh scaffold. In some embodiments, the proximal section ofthe collection member 134 comprises a first mesh layer having arelatively large pore size (e.g., greater than about 0.1 inch opening)and the distal section of the collection member 134 comprises the firstmesh layer having the relatively large pore size as an inner mesh layerand a second outer mesh layer having a relatively small pore size (e.g.,about 0.05 inch opening). The inner mesh layer and outer mesh layer canbe ultrasonically welded or otherwise coupled together at variouslocations (e.g., the proximal and distal ends of the outer mesh tube).For example, the distal ends of the two mesh layers can be coupledtogether and/or to the inner shaft 128 using heat seal, silicone orother suitable adhesive or heat shrink band clamps 160. In otherembodiments, the two mesh layers are coupled by sutures, epoxy,adhesive, other low-profile attachment devices, and/or the like. Theouter mesh layer can include an outer mesh ring 182 having therelatively large pore size that is ultrasonically welded or otherwiseconnected to the inner mesh layer at one or more locations adjacent tothe removal member 132. The outer mesh ring can have a conical orsubstantially conical shape. In some embodiments, both the proximalsection and the distal section of the collection member 134 comprise twoor more mesh layers.

In some embodiments, the length of the collection member ranges fromabout 0.2 inches to about 1 inch. In one embodiment, the length of thecollection member is about 0.4 inches. In some embodiments, the lengthis selected to effectuate a “tent-like” configuration when deployedinstead of a “sausage-like” configuration. The “tent-like” configurationadvantageously focuses the radial force along a perpendicular planethrough the removal member 132.

In some embodiments, the collection member 134 is expanded generallyuniformly across its length. For example, in its expanded configuration,the collection member 134 can exhibit a “tent-like” form, wherein thedistal half and the proximal half have a convex shape (as shown in FIG.6). In other embodiments, a proximal portion (e.g., the proximal half)of the collection member 134 can be configured to expand in a concavefashion and a distal portion (e.g., the distal half) of the collectionmember 134 can be configured to expand in a convex fashion. The proximaland distal portions can be integral or separate.

FIGS. 9A and 9B illustrate embodiments of the collection member 134having a convex distal section and a concave proximal section. Theconcave profile of the proximal portion can advantageously keep thesurface of the collection member 134 away from the inner wall of theendotracheal tube 100, thereby ensuring that the outer surface of theremoval member 132 is the only surface that comes in contact with theinner wall of the endotracheal tube 100. In some embodiments, theconcave profile advantageously results in more efficient biofilmcollection than the convex profile. For example, the concave profile cancreate more surface area and volume for collection of biofilm. In someembodiments, the collection member 134 is formed of two separateelements. The slight wave pattern of the removal member 132 in FIG. 9Bcan advantageously improve radial deployment of the collection member134, can improve collection due to its greater surface area, and/or canincrease the expandability of the removal member 132.

With reference to FIGS. 9C and 9D, the concave profile of the proximalsection of the collection member 134 can be effected by attaching one ormore rings 192 about the proximal section of the collection member 134to constrain the expansion. If multiple rings are used, the rings 192can be spaced apart and can be configured to expand to differentdiameters to effectuate a desired profile. In some embodiments, thelength of the collection member 134 can be increased with the inclusionof the rings 192 to constrain the expansion of the proximal section ofthe collection member 134. For example, the length of the collectionmember 134 can range from about 0.15 inches to about 2 inches. Thecollection member 134 can be constructed to have a capacity of about 15cubic centimeters (ccs) of biofilm or other material; however a capacityof less than or more than 15 ccs can be used as desired and/or required.

2. Removal Member

In general, the removal member 132 is configured to be expanded duringuse to come in contact with the interior surface of the endotrachealtube 100 (or other conduit) and to remove the deposited debris (e.g.,biofilm) therefrom as the cleaning device 120 is withdrawn from theendotracheal tube 100. In some embodiments, the removal member 132 isconfigured to engage the interior surface of the endotracheal tube 100with a smooth, regular outer surface. In other embodiments, the surfaceprofile of the removal member 132 can have an irregular shape. In oneembodiment, the removal member is flush with the outside periphery ofthe scaffold (which, in some embodiments can serve as a collectionmember). In other embodiments, the removal member protrudes beyond theoutside periphery of scaffold by about 0.05 mm to about 4 mm, such that,in some embodiments, only the removal member contacts the interiorsurface of the endotracheal tube (or other conduit).

In some embodiments, the removal member 132 comprises one or more soft,flexible, expandable materials, such as, for example, silicone, UVcurable silicone, ethylene vinyl acetate (EVA), thermoplastic elastomer(TPE), KRATON polymers, polyisoprene, urethane, silicone rubber, othersuitable flexible and low-tear materials, and/or the like.

In some embodiments, the removal member 132 has a material softness thatenables optimum deployment of the collection member 134 and reduces orprevents “hydroplaning” of the removal member 132 as it is withdrawn,thereby ensuring that the biofilm is removed in an efficient manner. Ifthe material is too soft, the removal member 132 can gradually tear orpull away from the collection member 134 over time.

In some embodiments, the use of materials that are too hard can retardthe deployment of the collection member 134, because the removal member132 exerts a backward force on the collection member 134 as it isexpanded. Failure to adequately deploy the removal member 132 canprevent the removal member 132 from adequately engaging the inside wallof the endotracheal tube 100 with sufficient radial force to effectivelyremove biofilm. In other embodiments, if the material is too soft, thenthe removal member 132 “hydroplanes,” thereby failing to adequatelyremove the biofilm as the endotracheal tube device 120 is withdrawn.

The softness of the removal member 132, as measured on a durometerscale, can range from 20 Shore A to 60 Shore A when silicone is used orfrom about 0 Shore A to about 40 Shore A when urethane or othermaterials are used. In one embodiment, the softness of the removalmember 132 is 30 Shore A when silicone or a similar material is used.The removal member 132 can be configured to expand to approximately 200to 250 percent of its nominal diameter. In some embodiments, the removalmember 132 can be configured to expand to accommodate endotracheal tubeshaving a diameter between about 1 to about 10 mm.

The removal member 132 can be removably or integrally coupled to thecollection member 134 using any suitable attachment method or device,including but not limited to, adhesive, epoxy, suture, welding, casting,mechanically connected interference fit, overmolding, and/or the like.In one embodiment, such as when the removal member 132 comprisesurethane material, the removal member 132 becomes chemically bonded tothe collection member 134 (e.g., a PET braid scaffold) when overmolded.In some embodiments, the removal member 132 is coupled to the outersurface of the collection member 134. In other embodiments, the removalmember 132 is coupled to the inner surface of the collection member 134.In yet other embodiments, the removal member 132 is detachable orseparable from the collection member 134. In still other embodiments,the removal member 132 is integral with the collection member 134. Inone embodiment, an integral well is formed underneath and through thecollection member 134 when the removal member is overmolded or formedwith an applicator. The integral well design can advantageously preventor reduce the likelihood of the removal member 132 being sheared fromthe collection member 134 during operation.

In one embodiment, the removal member 132 comprises an expandable O-ringwiper that generally circumscribes the collection member 134. The O-ringwiper can be circular, substantially circular, elliptical, oval, and/orany other shape. The O-ring wiper can be a single, smooth, regular,continuous bead that is in a perpendicular plane to the collectionmember 134. In another embodiment, the removal member 132 comprises awavy, or undulating, pattern (as shown, for example, in FIGS. 9B and9D). The peaks of the wave pattern can vary from between about 0.05inches to about 0.5 inches peak to peak, or e.g., about 0.1 inches toabout 0.35 inches.

FIGS. 10A-10H illustrate cross-sectional profiles of various alternativeembodiments of the removal member 132 mounted on a deployed collectionmember 134. In some embodiments, the portion of the removal member 132that contacts or engages the inner surface of the endotracheal tubeprovides a smooth, regular contact surface. In other embodiments, thecontact portion of the removal member 132 comprises an irregular contactsurface. FIG. 10A illustrates an O-ring having a substantiallytriangular cross section. The concave slope and radius of the edges ofthe substantially triangular O-ring can be varied as desired and/orrequired. FIG. 10B illustrates an O-ring having a quarter-circle crosssection. The quarter-circle O-ring of FIG. 10B can be tapered on thedistal side for minimal disruption of biofilm on introduction andoptimal wiping of biofilm on removal of the device. In some embodiments,the proximal side of the quarter circle O-ring of FIG. 10B is concave,thus forming an O-ring having a “wave-like” or “fin-like” cross section.

FIG. 10C illustrates an O-ring having a U-shaped cross section. FIG. 10Dillustrates an O-ring having a half-circle or half-moon shaped crosssection. The radius of the half-circle can range from about 0.001 inchesto about 0.1 inches, or greater, e.g., about 0.005 inches to about 0.01inches, about 0.01 inches to about 0.025 inches, about 0.025 inches toabout 0.05 inches, about 0.05 inches to about 0.1 inches, andoverlapping ranges thereof. FIG. 10E illustrates an O-ring having a“squeegee-like” cross section with a steep slope and a narrow wiping orscraping edge. FIG. 10F illustrates an O-ring having a half-circle crosssection with a parting line. The parting line has been emphasized forillustration and is not necessarily to scale. The parting line can be anatural or intentional result of the molding process in forming theO-ring. FIG. 10G illustrates an O-ring having a squared-off contactportion. FIG. 10H illustrates an O-ring having an X-shaped crosssection.

The removal member 132 can be constructed of two or more materials of anexpandable nature. In some embodiments, the majority of the body of theremoval member 132 comprises a material having a suitable durometer forexpansion and the contact portion comprises a more rigid material toprovide sufficient strength and rigidity for the effective wiping orremoval of biofilm.

FIG. 11A illustrates an embodiment of a removal member 132 having ahelical or “barber pole” configuration. Other embodiments of removalmember configurations include, but are not limited to, a ribbed O-ring,an O-ring having a full circle cross-section, and an O-ring having avarying cross-section about its circumference. In still otherembodiments, the removal member 132 can comprise shaving members,bristles, or other protrusions. In various embodiments, the removalmember can comprise bumpy, ribbed, saw-like, abrasive, rough, textured,slotted, and/or smooth or substantially smooth materials. In someembodiments, the removal member 132 can range from about 0.015 inches toabout 0.050 inches in height and from about 0.015 inches to about 0.1inches in width.

In some embodiments, the cleaning member 126 can include multipleremoval members 132, as illustrated in FIG. 11B. The multiple removalmembers 132 can have the same or different profiles. Different profilescan be used to accomplish various purposes, as will be described infurther detail below. In some embodiments, the multiple removal members132 include partial O-rings that extend around a partial circumferenceof the collection member 134 and are rotationally staggered.

In some embodiments, the removal member 132 can include holes orapertures for fluid delivery, for suction, and/or for any other purpose.The removal member 132 can be connected to a fluid delivery channel or asuction/aspiration conduit within the endotracheal tube cleaning device120. For example, the removal member 132 can be configured to deliverfluid and/or other materials that help to disperse, degrade, or loosenhardened, more adherent biofilm and/or to deliver drugs to theaccumulated biofilm and/or the internal surface of the endotrachealtube.

3. Multiple Cleaning Members

In some embodiments, the endotracheal tube cleaning device 120 includesmultiple cleaning members 126. The multiple cleaning members 126 can beconstructed to serve different purposes. For example, the removal member132 of each of the multiple cleaning members 126 can be constructed witha different profile or cross section. In other embodiments, each of theremoval members 132 can have the same profile or cross section. FIG. 12illustrates an embodiment of an endotracheal tube cleaning device 220having three cleaning members 226A-226C.

For example, the cleaning member 226A can include a round or half-circleO-ring 232A for removing the mucous and other easy-to-remove secretionsdeposited on the outer surface of the biofilm layer. The cleaning member226B can include an O-ring 232B having a scraping edge 233 for removingthe tenacious, more adherent, older biofilm deposits. With reference toFIGS. 13A-13C, various alternative embodiments of scraping edges 233 areillustrated. Other scraping edge profiles can be used without departingfrom the spirit and/or scope of the disclosure. Referring back to FIG.12, the cleaning member 226C can include a round, half-circle, orquarter-circle O-ring 232C configured to remove and collect anyremaining biofilm. As described above, the O-ring removal members 232can be constructed of more than one material to enhance the scraping orwiping action of the O-rings. The O-rings 232 of the cleaning members226 can have any of the cross-sectional profiles illustrated in FIGS.10A-10H or any other cross-sectional profiles as desired and/orrequired.

Each of the cleaning members 226 can include a collection member 234(e.g., braided or mesh scaffold) for collecting biofilm while stillallowing sufficient airflow through the endotracheal tube 100. Themultiple cleaning members 226 can be separated by a non-expandableattachment device or method, such as, for example, a heat shrink clampband, sutures, adhesives, epoxy, welding, other low-profile mechanicalattachment methods or devices, and/or the like. For example, as shown inFIG. 12, the multiple cleaning members 226 are separated by clamp bands235 that constrain the expansion of the mesh collection members but arenot attached to the inner shaft 128, thereby allowing for simultaneousdeployment of the multiple cleaning members 226.

4. Separate Collection Member

FIG. 14 illustrates another embodiment of an endotracheal tube cleaningdevice 240. The endotracheal tube cleaning device 240 includes a removalmember 242 and a collection member 244. The removal member 242 includesan O-ring wiper 246 and a scaffold 248 (e.g., mesh scaffold) forselectively effectuating deployment of the O-ring wiper 246. In thedepicted embodiment, the collection member 244 comprises a biofilmcollection basket. The collection member 244 can be spaced proximallyfrom the removal member 242 at a distance ranging from about 0.1 inchesto about 0.5 inches; however other separation distances can be used asdesired and/or required.

The collection member 244 can comprise a mesh or other porous materialhaving openings that are small enough to collect solid or semi-solidbiofilm deposits but large enough to allow for sufficient airflowthrough the collection member. In some embodiments, the maximumcross-sectional dimension of the openings ranges from about 0.010 inchesto about 0.050 inches. The collection member 244 can be sized and shapedto hold up to about 20 ccs of biofilm. The collection member 244 canadvantageously have a width or diameter that is less than the diameterof the endotracheal tube 100 so as not to contact the inner wall of theendotracheal tube 100. As shown in FIG. 14, the endotracheal tubecleaning device 240 can include an internal channel 249 for insertion ofscopes (e.g., a visualization scope), catheters, probes, and/or otherinstruments, as described in greater detail herein. The endotrachealtube cleaning device 240 can include an inner shaft and outer shaft, aswell as other structural features not shown in FIG. 14, but describedwith respect to the other embodiments herein.

5. Outer Sleeve Surrounding Expansion Member

FIG. 29A illustrates another embodiment of an endotracheal tube cleaningdevice 2920. As shown, the endotracheal tube cleaning device 2920 cancomprise an elongate body 2922 having a pre-defined curvature thatapproximates the curvature of an endotracheal tube. However, theendotracheal tube cleaning device 2920 can also comprise an elongatebody 2922 that is generally straight, thereby facilitating introductioninto a patient-inserted endotracheal tube that conforms to the patientairway in an S shape. In one embodiment, the cleaning member 2926 at thedistal end of the endotracheal tube cleaning device 2920 comprises anexpansion member and an outer sleeve (e.g., an elastomeric sleeve) 2905.Expansion of the expansion member using the actuation assembly 124 cancause the expansion of at least a portion of the outer sleeve. Theendotracheal tube cleaning device 2920 can include a scope retentionassembly 2925, which is described in more detail below with respect toFIGS. 33A-33G. FIG. 29B illustrates a close-up perspective view of thedistal end of the endotracheal tube cleaning device 2920 of FIG. 29A. Insome embodiments, the elastomeric sleeve 2905 surrounds the expansionmember (not shown) in a concentric fashion. The expansion member cancomprise an expandable scaffold that includes one or more expandable andcollapsible struts. In other embodiments, the expansion member comprisesan expandable and collapsible mesh or braided scaffold. In someembodiments, the expansion member is non-inflatable and mechanicallyactuated. Such expandable scaffolds can be air permeable or non-airpermeable. In some embodiments, the expansion member is notself-expandable upon removal of a surrounding sheath. In someembodiments, the outer sleeve is not a sheath that is withdrawn to causean expandable member to be deployed. The terms expandable member,expansion member, expansion structure, and expandable structure are usedinterchangeably herein.

With continued reference to FIG. 29B, the cleaning member 2926 cancomprise one or more cutouts, air gaps, holes, or vents 2915 at or nearthe proximal and distal ends of the elastomeric sleeve 2905. In severalembodiments, 1, 2, 3, 4, 5, 6-8, 8-10, and 10 or more cutouts, air gaps,holes or vents are provided at the ends or along the sleeve. Suchfeatures can allow for air exchange through the cleaning member 2926during expansion. The sleeve may comprise breathable or porous materialto facilitate air exchange. For example, in embodiments wherein a meshscaffold is used, the mesh scaffold is exposed to the air through theair gaps and air can flow through the interstices of the mesh scaffoldfrom one air gap to the other. The air gaps or vents 2915 canadvantageously prevent formation of a vacuum effect during removal ofthe cleaning device 2920 (e.g., within an endotracheal tube, along thedistal end of the cleaning member), which can result in hydroplaningand/or increase the pull-out force required to remove the cleaningdevice. The width of the air gaps 2915 can range from 0.005 inches to0.500 inches, from 0.050 inches to 0.250 inches, from 0.060 inches to0.180 inches, and/or overlapping ranges thereof to allow for adequateair exchange through the cleaning member 2926.

In some embodiments, the endotracheal tube cleaning device 2920optionally comprises a distal heat-shrink tubing cover 2935A between thedistal air gap and the distal tip 2945 and a proximal heat-shrink tubingcover 2935B disposed over the outer shaft 129 proximal to the proximalair vent 2915B. The heat-shrink tubing covers 2935A, 2935B can beprovided for aesthetic purposes. In other embodiments, the heat-shrinktubing covers 2935A, 2935B can aid in retention of one or morecomponents and/or provide additional benefits or advantages.

FIG. 29C illustrates a cross-sectional view of the distal end of theendotracheal tube cleaning device 2920. The depicted assembly of theendotracheal tube cleaning device 2920 is similar to the assembliesdescribed above. In the illustrated embodiment, the expansion membercomprises a mesh or braided scaffold 2940. The distal end of the meshscaffold 2940 can be adhered or otherwise secured to the distal tip 2945of the endotracheal tube cleaning device 2920, which is in turn adheredor otherwise secured to the distal end of the inner shaft 128. In someembodiments, the proximal end of the mesh scaffold 2940 is adhered tothe distal end of the outer shaft 129. The mesh scaffold or otherexpansion member 2940 can be adhered with any suitable coupling and/orattachment device or method, such as, for example, interference fits,ultrasonic welding, heat shrink tubing, adhesive, epoxy, NuSil MED2-4013silicone adhesive, other low-profile mechanical attachment means, and/orthe like. As shown, a visualization scope 2950 can be inserted withinthe inner shaft 128 such that the distal end of the visualization scope2950 is pressed against a viewing window 2955 of the distal tip 2945.Such a configuration can allow for visualization beyond the distal endof the endotracheal tube.

The sleeve 2905 can vary in length from approximately 0.25 inches toapproximately 3 inches, from approximately 0.5 inches to approximately1.5 inches from approximately 0.75 inches to approximately 1 inch,greater, and/or overlapping ranges thereof. In some embodiments, thesleeve is partially or fully elastomeric. In some embodiments, theelastomeric sleeve 2905 comprises thermoplastic elastomer (TPE),silicone; however, other elastomers, polymers and/or other materials canbe used, either in lieu of or in addition to silicone, as desired and/orrequired. The elastomeric sleeve 2905 can comprise elastomeric materialshaving a Shore A durometer of between 15 and 50 and a wall thickness ofbetween 0.005 inches and 0.05 inches. For example, in some embodiments,the elastomeric sleeve 2905 comprises a material having a 25 Shore Adurometer and a 0.010-inch wall thickness; however, other durometervalues and thicknesses can be used as desired and/or required. In someembodiments, the wall thickness or durometer value of the elastomericsleeve 2905 varies across its length to improve the shape uponexpansion. For example, the wall thickness can be thinner and/or have alower durometer value in the center of the sleeve 2905. The outerdiameter of the elastomeric sleeve 2905 can be sized to receive avisualization scope of less than 2 mm. In some embodiments, the outerdiameter of the elastomeric sleeve is between about 0.1 inches and 0.2inches (e.g., about 0.100 inches, 0.125 inches, 0.150 inches, 0.175inches, 0.200 inches).

The elastomeric sleeve 2905 can be assembled to the mesh scaffold 2940with a slight interference (inner diameter of the sleeve to the outerdiameter of the scaffold). For example, the interference can vary from0.001 inches to 0.025 inches per side. The elastomeric sleeve 2905 canbe attached to the mesh scaffold 2940 with an adhesive and/or any otherconnection material, device or method. The adhesive can be appliedunderneath the sleeve 2905 and circumferentially for a distance ofapproximately 0.25 inches on each side. Advantageously, the adhesivecomprises quick setting properties, has a sufficiently high viscosity toprevent running during setting, and is flexible when set. Theflexibility of the adhesive can permit the adhesive to move with themovement of the fibers during distension of the mesh scaffold 2940. Insome embodiments, the adhesive comprises a NuSil MED2-4013 siliconeadhesive. The adhesive can be selected to accommodate a shear force ofapproximately three to six pounds; which, in some embodiments, canprovide a significant safety factor of two to four times when comparedto the required pull force. The adhesive can be configured to retain theelastomeric sleeve 2905 on both sides so that the elastomeric sleeve2905 can distend to the preferred shape upon expansion of the expansionmember 2940 (e.g., mesh scaffold).

In embodiments wherein a mesh scaffold is used, the scaffold cancomprise a mesh having four to fourteen picks per inch, eight to twelvepicks per inch, six to ten picks per inch, and/or overlapping rangesthereof. In other embodiments, the mesh of the scaffold can a pick countof less than four picks per inch or greater than fourteen picks perinch. The mesh scaffold 2940 can comprise fibers having a diameter ofbetween 0.002 inches and 0.050 inches, between 0.005 inches and 0.020inches, less than 0.002 inches, greater than 0.050 inches and/oroverlapping ranges thereof. The mesh scaffold 2940 can comprise betweenten and sixty strands of fibers (e.g., 12 end, 24 end, 48 end); howeverfewer than ten and greater than sixty strands of fibers can be used asdesired and/or required. In some embodiments, the mesh scaffold 2940comprises a 48 end, 0.010-inch fiber diameter scaffold having 12 picksper inch. However, other parameters can be selected to alter the radialforce exerted on the elastomeric sleeve 2905 and the shape of theelastomeric sleeve 2905 formed upon expansion. The mesh scaffold 2940can comprise one or more mesh layers. In some embodiments, the fiberscomprise nylon fibers; however, other fiber materials can be used, suchas PET, polyester, polypropylene and/or other extrudable plastic resinsthat are flexible in the extruded state, either in lieu of or inaddition to nylon fibers.

FIG. 29D illustrates the outer sleeve 2905 upon expansion of theexpansion member 2940 by manipulation of the actuation assembly 2924. Asshown, the material properties of the expansion member 2940 (e.g., meshscaffold) and the outer sleeve 2905 can be selected such that thecentral portion of the outer sleeve 2905 forms a removal member 2960upon expansion of the expansion member 2940. In some embodiments, theremoval member 2960 comprises a disc-like or disc-shaped removal member.The terms disc-like and disc-shaped as used herein can be usedinterchangeably to refer to a generally disc-shaped structure. Asdiscussed in greater detail herein, in other embodiments, the removalmember comprises shapes other than generally disc shapes. The removalmember 2960 can comprise a steep, substantially vertical slope on eachside of the removal member 2960. The disc-like shape can advantageouslyprovide a smooth, regular contact surface over a highly concentrateddistance against the inner wall of the endotracheal tube. In someembodiments, the material properties of the expansion member and theelastomeric sleeve 2905 provide an increased radial pressure at acentralized, concentrated location. This concentrated increased radialpressure can help form the removal member 2960 which, as shown in FIG.29D, can have a more disc-like profile than a convex, “football-shaped”profile (e.g., as viewed from the side).

In some embodiments, the removal member 2960 is generally symmetricalabout the longitudinal axis of the cleaning member and/or about atransverse axis or plane of the removal member 2960 (e.g., along an axisperpendicular to the longitudinal axis of the cleaning member or anyother axes or planes). In other embodiments, the removal member 2960 isasymmetrical about one or more axes of the cleaning member. In someembodiments, the removal member 2960 formed on the sleeve 2905 comprisesa bell curve-like cross-section (e.g., Gaussian curve) or an A-frame ortent-shaped cross-section on each side of the longitudinal axis of theremoval member 2960 when viewed from the side of the cleaning device2920, or forms a smooth apex having a relatively steep slope. In someembodiments, the apex of the removal member 2960 comprises a generallynarrow, rounded profile. In other embodiments, the apex is generallysquared or pointed. The width of the removal member 2960 can range fromabout 0.10 to about 0.80 inches (e.g., about 0.10 to about 0.60 inchesor about 0.15 to about 0.75 inches). In other embodiments, the width canbe less than about 0.10 inches or greater than about 0.80 inches. Thewidth of the removal member 2960 formed generally near the center of theouter sleeve 2905 can comprise about 10 to 40% of the total length ofthe outer sleeve 2905 in the expanded, or distended, configuration. Inother embodiments, the width of the removal member 2960 can compriseless than 10% or greater than 40% of the total length of the outersleeve 2905 in the expanded, or distended, configuration. In oneembodiment, the removal member 2960 advantageously allows an operator toremove at least about 90% or 95% of the biofilm in one or two passeswith approximately 1.5 lbs of pull force. However, in alternativeembodiments, the percentage of biofilm removed for any particularpulling force can vary (e.g., less than about 90%, more than about 95%,etc.).

According to some embodiments, as discussed in greater detail herein,the outer sleeve 2905 can be configured to selectively form a removalmember having a side cross-sectional or side view (when viewed from theside of the cleaning device) that is bell-shaped (e.g., in half-sectionor the portion that extends along only one side of the sleeve),tent-shaped or triangular-shaped (e.g., half-section), diamond-shaped(e.g., in full-section or as it extends along both sides of the sleeve),or disc-shaped (e.g., full-section). The side cross-sectional view canbe taken by cutting the removal member formed on the outer sleeve inhalf from the proximal end to the distal end along the longitudinal axisof the elongated body and viewing the removal member from the side ofthe cleaning device. In some embodiments, bell-shaped and tent-shapedrefers to the shape of the upper half-section or lower half-section of agenerally diamond-shaped removal member. Further, for any of the sleeveembodiments disclosed herein, the removal member can have generallyvertical and/or sloped sides along one or both sides of the top orbottom apex. In addition, for any of the embodiments disclosed herein,the removal member, as viewed from the side or in cross-section, can begenerally symmetrical about an axis perpendicular to the adjacent wallof the endotracheal tube or other medical tube being cleaned. In otherembodiments, the removal member can be asymmetrical about such an axis.

In some embodiments, the length of the outer sleeve 2905 (e.g.,elastomeric sleeve) decreases upon expansion of the expansion member2940 (e.g., mesh scaffold). In some embodiments, the length of the outersleeve 2905 decreases by between about 0.10 inches to about 0.90 inches(e.g., about 0.15 inches to about 0.60 inches) or by between about 4 mmto about 24 mm (e.g., about 8 mm to about 16 mm) between thefully-collapsed configuration and the fully-expanded configuration(depending on the inner diameter of the endotracheal tube). In someembodiments, the length of the outer sleeve 2905 decreases by about 5 to45% (e.g., about 10 to 30%, about 15 to 35%) between the fully-collapsedconfiguration and the fully-expanded configuration (e.g., depending onthe inner diameter of the endotracheal tube).

In one embodiment, the removal member 2960 is dimensioned to exertsufficient pressure against the interior wall of a tube (including, butnot limited to, a medical tube such as an endotracheal tube) so as toremove debris from the tube without causing significant (or any)invagination. The removal member may or may not be disc-shaped. In someembodiments, the removal member comprises a non-sharp and smoothsurface. In some embodiments, the removal member comprises a non-sharpand roughened surface. In one embodiment, the removal member allows asingle operator to remove at least about 90% or 95% of debris (such asbiofilm) in less than 3 passes with about 0.5-3 lbs of pull force (e.g.,0.5 lbs, 1 lb, 1.5 lbs, 2 lbs, 2.5 lbs, 3 lbs). Removal of at least 90%of all debris is accomplished in less than 90 seconds in someembodiments (e.g., less than about 60 seconds, 30 seconds, 15 seconds,10 seconds, and 5 seconds).

III. Mechanical Expansion

As described above, according to some embodiments, the cleaning member126 can be configured to transition from a collapsed configuration (seeFIG. 3D) to an expanded configuration (see FIG. 3E) by the relativemovement of inner and outer members (e.g., inner shaft 128 and outershaft 129). In some embodiments, the inner member moves axially whilethe outer member remains stationary. In other embodiments, the outermember moves axially while the inner member remains stationary. In yetother embodiments, the inner and outer members are both configured tomove axially.

A. Mechanical Struts

In some embodiments, the cleaning member 126 can be mechanicallyexpanded by multiple deploying struts. FIG. 15A illustrates a “fish-net”embodiment of the collection member 134. The proximal section of thecollection member 134 comprises multiple “umbrella-like” deployingstruts 252 to effectuate radial expansion of the removal member 132 andthe distal section of the collection member 134 comprises a meshscaffold, or collection basket, constructed to collect and trap biofilmremoved by the removal member 132. The deploying struts 252 can becoined to provide flexibility for a desired expansion angle. Theexpansion angle can range from about 5 degrees to about 45 degrees orfrom about 20 degrees to about 35 degrees. As shown, the deployingstruts 252 can extend from the outer shaft 129 to the removal member132. The deploying struts 252 can be mechanically coupled and/or adheredto the outer shaft 129 and the removal member 132 by any suitablecoupling and/or adhesive device or method, such as interference fits,ultrasonic welding, heat shrink tubing, adhesive, epoxy, otherlow-profile mechanical attachment means, and/or the like. As shown, thedeploying struts 252 are coupled to the outer shaft 129 by a heat shrinkband clamp 254. The deploying struts 252 can comprise one or moremetallic and/or plastic materials. Nitinol can be used in severalembodiments to form expanding components, such as the struts, scaffold,removal member, etc.

FIGS. 15B and 15C illustrate another embodiment of a “living hinge”endotracheal tube cleaning device 250 comprising deployment struts formechanical expansion of a cleaning member 251. The cleaning member 251illustrated in FIGS. 15B and 15C comprises a scaffold having deploymentstruts 256 and longitudinal slits 258 and an O-ring wiper 259. In someembodiments, the distal tip 130 of the endotracheal tube cleaning device120 is integrally formed with distal end of the cleaning member 251. Thedistal tip 130 of the endotracheal tube cleaning device 120 can becoupled to the inner shaft 128 and the proximal end of the cleaningmember 251 can be coupled to the outer shaft 129 by any suitablecoupling and/or adhesive device or method, such as interference fits,ultrasonic welding, heat shrink tubing, adhesive, epoxy, otherlow-profile mechanical attachment means, and/or the like. In someembodiments, the connections between the distal end of the cleaningmember 241 and the distal tip 130 or inner sheath 128 and/or theconnection between the proximal end of the cleaning member 241 and theouter sheath 129 form living hinges about which the deployment strutsexpand. The O-ring wiper 259 can be coupled and/or adhered to thedeploying struts 258 by overmolding, interference fits, ultrasonicwelding, adhesive, sutures, epoxy, other low-profile mechanicalattachment means, and/or the like. In some embodiments, movement of theinner shaft in a proximal direction causes the deploying struts 258 toflex or bend outward, thereby radially expanding the O-ring wiper 259.The deploying struts can comprise a substantially rigid elastomericmaterial to prevent collapse due to the return force of the O-ring wiper259.

B. Expanding Collet Assemblies

FIG. 16A-16D illustrate other mechanisms for mechanical expansion of aremoval member (e.g., an O-ring) of an endotracheal tube cleaningdevice. FIGS. 16A and 16B illustrate an embodiment of a collet expansionassembly 210 in an unexpanded and expanded configuration, respectively.The collet expansion assembly 210 includes an expanding collet 212 thatcan be radially expanded by a ram 214.

The expandable collet 212 can comprise elastomeric material, such aspolypropylene, polyethylene, nylon, polycarbonate, and/or the like. Theelastomeric material can advantageously provide living hinge capability.The expandable collet 212 comprises multiple (e.g., four or more)struts, or leaves, 216 and multiple longitudinal openings, or slits, 217to allow for radial expansion.

The ram 214 can be fixedly attached to the outer shaft 129, therebyremaining stationary. The ram 214 can have a circular, substantiallycircular, elliptical and/or other shaped cross section. The ram 214 canhave a uniform cross-sectional diameter across its length or a varyingcross-sectional diameter. The distal end of the ram 214 can have atapered edge so as to reduce the likelihood that the expandable collet212 is snagged on the ram 214. The distal end of the expandable collet212 can be connected to and/or can be integral with the distal tip 130of the endotracheal tube cleaning device and the inner sheath 128 can beconnected to the distal tip 130.

As the inner shaft 128 is pulled proximally, the expandable collet 212can be pulled toward the ram 214. As the inner surface of the struts 216engage and move over the ram 214, they can be expanded radially by theram 214 about living hinges 218 formed between the distal ends of thestruts 216 and the distal tip 130. As the struts 216 of the expandablecollet 212 expand, the removal member 132 can also expand. FIG. 16Billustrates the collet expansion assembly 210 in an expanded position.As shown in FIG. 16B, upon expansion, the open proximal side of theexpandable collet 212 can function as a collector of biofilm as theendotracheal tube cleaning device is withdrawn from the endotrachealtube. In some embodiments, a mesh or other porous material can becoupled to the expandable collet 212 to facilitate collection of biofilmwhile still allowing airflow through the endotracheal tube cleaningdevice. In other embodiments, the ram 214 can move with respect to theexpandable collet 212.

The removal member 132 can be overmolded, applicated, assembled,adhered, and/or otherwise coupled to the expandable collet 212. In someembodiments, the removal member 132 sits within a circumferential grooveof the expandable collet 212. The removal member 212 can be an O-ringcomprised of TPE, silicone, urethane, ethylene-vinyl acetate (EVA),polyisoprene, a KRATON polymer, and/or the like. The durometer of theO-ring can range from about 30 Shore A to about 90 Shore A. In otherembodiments, the removal member 132 is not included.

FIG. 16C illustrates a collet expansion assembly 260 of an embodiment ofthe endotracheal tube cleaning device 120 and the endotracheal tube 100.In the depicted embodiment, the collet expansion assembly 260 includes acenter rod 262, a molded collet 264, a split tubing 266, an expandingnetting 268, and a molded adhesion band 269. FIG. 16D illustrates theassembled collet expansion assembly 260 in its expanded configurationwithin the endotracheal tube 100. In some embodiments, the center rod262 replaces the inner shaft 128, the split tubing 266 replaces theouter shaft 129, and the expanding netting 268 replaces the collectionmember 134. As shown in FIG. 16D, the molded collet 264 is inserted overand attached to the center rod 262, which in turn is inserted within thesplit tubing 266, the expanding netting 268 is placed over the splittubing 266, and the molded adhesion band 269 is overmolded on the distalend of the expanding netting 268. The expanding netting 268 can beconnected to the center rod 262 by the molded adhesion band 269. As thecenter rod 262 moves proximally, the increasing diameter of the moldedcollet 264 causes the split tubing 266 to expand radially, therebybringing the expanding netting 268 into contact with the inner wall ofthe endotracheal tube. As the center rod 262 is withdrawn, biofilmremoved by the expanding netting 268 can collect within the expandingnetting 268, similar to the collection members described herein.

C. Vented Tube Design

FIGS. 17A and 17B illustrate an embodiment of a vented tube assembly270. The vented tube assembly 270 includes a center rod 272, a ventedtube 273, and a vented tip 275. As shown in FIG. 17B, the center rod 272is inserted within the vented tube 273. The vented tip 275 can beattached to the distal end of the center rod 272. The distal tip of thevented tube 273 can be tapered such that when the center rod 272 ismoved proximally with respect to the vented tube 273, the roundedproximal edge of the vented tip 275 slides over the tapered distal tipof the vented tube 273, and expands radially with the increasingdiameter of the vented tube 273. The vents in the vented tube 273 canallow the vented tube 273 to expand. In some embodiments, the proximaledge of the vented tube 273 comprises a circumferential ridge orprotrusion configured to engage the inner surface of the endotrachealtube 100 and to remove biofilm deposited thereon as the center rod 272is withdrawn from the endotracheal tube 100. In other embodiments, anO-ring can be overmolded or otherwise coupled about the circumference ofthe vented tube 273.

In some embodiments, the vented tip 275 can be expanded by infusion ofair and/or liquid through the vented tube 273. In some embodiments,therapeutic agents, drugs, and/or gases can be delivered through thevented tip 275 and/or biofilm can be aspirated out of the endotrachealtube 100 through the vented tube 273. The vented tip 275 can compriseone or more durable elastomeric materials, such as silicone, urethane,polypropylene, polyethylene, and/or the like.

FIGS. 17C-17E illustrate another embodiment of a vented cleaning member1770 configured for use in an endotracheal tube cleaning device. FIGS.17C and 17D illustrate perspective and cross-sectional views,respectively, of the vented cleaning member 1770. As shown, the ventedcleaning member 1770 can comprise a mechanically-expandable bellows-likeexpansion structure. The vented cleaning member 1770 can include one ormore injection-moldable elastomeric materials, such as, for example,natural rubber, synthetic rubber, other elastomeric or polymericmaterials and/or the like.

In some embodiments, the vented cleaning member 1770 is generallytubular and comprises a proximal end 1772, a distal end 1774 and a body1776 situated therebetween. As shown, the body 1776 of the ventedcleaning member can comprise a varying cross-section along its length.For example, in one embodiment, the cross-sectional dimension is largertowards the proximal and distal ends and smaller near the center of thebody 1776. The connections between the body 1776 and the proximal anddistal ends can comprise living hinges 1777 or similar features aboutwhich the body 1776 hinges to radially expand a removal member 1778positioned in the center of the body 1776. The removal member 1778 cancomprise a tapered ring that presents a squeegee-like contact surfacewhen expanded; however, other profiles or shapes can be used as desiredand/or required.

According to some embodiments, the proximal and distal ends of thevented cleaning member 1770 comprise a plurality of vents, or openings,1779 to allow for airflow through the vented cleaning member 1770 uponexpansion. As noted above, such a feature can help prevent a vacuumeffect from being created when the cleaning member is moved relative tothe endotracheal tube. In some embodiments, the proximal end 1772 of thevented cleaning member 1770 abuts, but is not adhered to, the outershaft 129. Likewise, the distal end of the vented cleaning member 1770abuts, but is not necessarily adhered to the distal cap adhered at thedistal end of the inner shaft 128. In some embodiments, the ventedcleaning member 1770 is “free-floating” on (e.g., is not adhered to) theinner shaft 128.

FIG. 17E illustrates one embodiment of the vented cleaning member 1770expanded within an interior of the endotracheal tube. As the inner shaft128 is pulled toward the actuation assembly 124, the vented cleaningmember 1770 is axially compressed, thereby causing radial expansion ofthe body 1776 about the living hinges 1777. Upon expansion, the removalmember 1778 engages the inner surface of the endotracheal tube. As thecleaning device is withdrawn from the endotracheal tube, the removalmember 1778 removes at least a portion of the biofilm adhered to theinner surface of the endotracheal tube. As discussed in greater detailherein, the level of radial expansion of the vented cleaning member1770, and thus the corresponding force imparted by the removal member1778 along the interior wall of the endotracheal tube, can beselectively varied by the clinician or other user, as desired orrequired for a particular procedure.

In some embodiments, the length of the vented cleaning member 1770 inthe relaxed or compressed configuration is between about 10 mm and 20 mm(e.g., between about 10 mm and 12 mm, between about 12 mm and about 15mm, between about 14 mm and about 18 mm, between about 16 mm and about20 mm, or overlapping ranges thereof). In other embodiments, the lengthof the vented cleaning member 1770 in the relaxed or compressedconfiguration is greater than 20 mm or less than 10 mm. The length ofthe vented cleaning member 1770 in the fully expanded configuration isbetween about 10 mm and 35 mm (e.g., between about 20 and 25 mm). Inother embodiments, the length of the vented cleaning member 1770 is lessthan about 10 mm or greater than about 35 mm. In some embodiments, thelength of the vented cleaning member 1770 decreases by about 20 to 50%(e.g., by about 28 to 43%) between the fully compressed configurationand the fully expanded configuration (depending on the inner diameter ofthe endotracheal tube).

D. Spring Assemblies

FIGS. 18A-18C illustrate other embodiments of mechanical expansionmechanisms using helical springs. With reference to the embodimentsillustrated in FIG. 18A-18C, the distal end of the helical springwireform 180 is attached to the inner sheath 128 and the proximal end ofthe helical spring wireform is attached to the outer sheath 129. Thehelical spring wireform 180 can be attached to the inner sheath 128 andthe outer sheath 129 by any suitable attachment method or device, suchas, for example, heat shrink tubing, adhesive, epoxy, interference fits,other low-profile mechanical attachment methods and/or the like.

In some embodiments, as shown in FIG. 18A, the helical spring wireform180 is wound or otherwise manufactured such that the middle portion 182comprises a slightly unstable, naturally unfurled configuration. Whenthe inner shaft 128 is engaged by the trigger 152 (thereby moving theinner sheath 128 in a proximal direction, the inner sheath 128compresses or draws the helical spring wireform 180 proximally, and themiddle portion 182 is distended radially. In other embodiments, as shownin FIG. 18B, the helical spring wireform 180 is wound or otherwisemanufactured such that the middle portion 182 comprises a naturallydistended configuration. Before insertion of the endotracheal tubecleaning device of FIG. 18B, the actuation assembly 124 can beconfigured to move the outer sheath 129 proximally to draw the middleportion 182 of the helical spring wireform 180 to an unfurledconfiguration. Once the middle portion 182 has been properly positionedwithin the endotracheal tube, the trigger 152 can be released to returnthe middle portion 182 to its distended configuration for engaging theinner surface of the endotracheal tube 100.

The helical springs 180 of FIGS. 18A-18C can comprise one or moremetallic and/or plastic materials, such as, for example, stainlesssteel, spring steel, Nitinol, injection-molded polycarbonate and/or anyother injection-molded plastic material that is capable of retainingspring qualities. In some embodiments, the diameter of the spring wirecan range from about 0.001 inches to about 0.05 inches in diameter, orfrom about 0.005 inches to about 0.025 inches in diameter. The middleportion 182 can comprise from about 1 to about 3 turns (e.g., 1⅛ toabout 1¾ turns). In some embodiments, at least the outermost loop 185 ofthe distended middle portion 182 is coated with plastisol, silicone,other suitable elastomers, and/or the like, to aid in wiping andcollecting biofilm as the endotracheal tube cleaning device 120 iswithdrawn from the endotracheal tube 100.

In some embodiments, as illustrated in FIG. 18C, a thin, flexible funnel186 extends from the distal end of the inner shaft 128 or the distal tip130 of the endotracheal tube cleaning device 120 to the middle spring185 of the middle portion 182 of the helical spring wireform 180. Thefunnel 186 can advantageously serve as a collector of biofilm when theendotracheal tube device 120 is withdrawn from the endotracheal tube100. The funnel 186 can be attached to the inner shaft 128 or the distaltip 130 and to the helical spring wireform 180 by any suitableattachment method or device, such as, for example, heat shrink tubing,adhesive, wound wire, suture, epoxy, other low-profile mechanicalattachment method or device, and/or the like. The funnel can be attachedto the helical spring wireform 180 continuously or intermittently (e.g.,at selected attachment locations) using any attachment method or device,such as adhesive, flexibly epoxy, sutures, and/or the like. The funnel186 can comprise latex, thin braid material, silicone, and/or otherelastomeric or polymeric materials, flaccid materials and/or the like.The funnel can be draped over the helical spring wireform 180 withenough spare material to allow for expansion of the helical spring tothe distended configuration without substantially retarding or otherwisehindering deployment of the helical spring. In other embodiments, thehelical spring 180 can serve as its own collector without the funnel186.

E. Self-Expanding

In some embodiments, the collection member 126 can include one or more“self-expanding” materials that are configured to radially expand when acompressive force is exerted upon the materials in a longitudinaldirection by the movement of the inner shaft 128. The radial expansionof the collection member 126 causes the radial expansion of the removalmember 132. The term “self-expanding” as used herein shall be given itsordinary meaning and shall mean, without limitation, that no additionalmechanical structure (such as struts, collets, springs, pistons, and/orthe like) other than the physical characteristics or properties of thematerials of the collection member (e.g., scaffold), is used to expandthe collection member. In several embodiments, the collection membercomprises a sleeve (an elastomeric sleeve). For example, self-expandingmaterials can simply expand with the relative movement of the innershaft 128 with respect to the outer shaft 129. In some embodiments,self-expanding materials comprise Nitinol, other shape-memory metals,alloys or other materials and/or the like.

FIGS. 19A and 19B illustrate another embodiment of amechanically-expandable cleaning member 290. FIG. 19A illustrates aperspective view of the mechanically-expandable cleaning member 290 andFIG. 19B illustrates a cross-sectional view of themechanically-expandable cleaning member 290. FIGS. 19A and 19Billustrate the mechanically-expandable cleaning member 290 in theexpanded configuration. As shown, the cleaning member 290 can include anexpandable collection member or scaffold 292 and a removal member 294having an angled rim 295 for contacting the internal surface of theendotracheal tube 100. The angled rim 295 can be angled about 2 to about40 degrees (e.g., 5 to 25 degrees) from a vertical orientation.

The expandable collection member 292 can comprise an outer scaffoldmember 296 and an inner scaffold member 298. In the depicted embodiment,the inner scaffold member is folded in on itself and forms a hinge aboutwhich it expands. In the depicted embodiment, the distal end of theouter scaffold member 296 is connected to the distal tip 130 of theendotracheal tube cleaning device 120. The distal end of the outerscaffold member 296 can be connected to the distal tip 130 using heatshrink tubing, an interference fit, other fasteners, or other suitablelow-profile mechanical devices and/or any other attachment method ordevice. The inner sheath 128 can be assembled to or be formed integralwith the distal tip 130. Likewise, a first end of the inner scaffoldmember 298 can be connected to the distal end of the outer shaft 129using any attachment device or method, including, for example, aninterference fit, heat shrink tubing, adhesive, epoxy, molding, weldingand/or the like. The second end of the inner scaffold member 298 and theproximal end of the outer scaffold member 296 can be connected to theremoval member using any attachment device or method, including, forexample, an interference fit, heat shrink tubing, adhesive, epoxy,molding, welding and/or the like.

With continued reference to the embodiment illustrated in FIGS. 19A and19B, when the inner shaft 128 is pulled back (i.e., moved proximallywith respect to the outer shaft 129), a force can be exerted on theouter scaffold member 296 by the inner shaft 128 and the inner scaffoldmember 298 that causes the angled rim 295 of the removal member 294 todistend radially against the inner wall of the endotracheal tube 100. Insome embodiments, the inner scaffold member 298 of the expandablecollection member 292 can also exert a radial expansion force on theremoval member 294 as the inner sheath 128 moves in a proximaldirection. The expandable collection member 292 includes a collectionarea within the interior of the outer scaffold member 296 and/or theinner scaffold member 298 for collection of biofilm as the endotrachealtube cleaning device 120 is withdrawn from the endotracheal tube. Thescaffold of the expandable collection member 292 can comprise one ormore braid materials, elastomeric or polymeric materials, such as, forexample, polyisoprene, TPE, silicone, urethane, and/or any othersuitable material that has the desired or required softness and/or othercharacteristics (e.g., a softness of about 15 to about 40 Shore Adurometer). The inner scaffold member 298 of the expandable collectionmember 292 can comprise strengthening materials to provide sufficientrigidity (e.g., larger diameter braided fibers or stiff porouselastomeric material).

The outer scaffold member 296 and the inner scaffold member 298 can beconfigured to have varying porosity to facilitate expansion and/orcollection of biofilm. For example, in embodiments where braidedmaterial is used for the expandable collection member 292, a lower pickcount (e.g., about 5 to about 10 picks per inch) can be used for theproximal side, while a higher pick count (e.g., about 10 to about 25picks per inch) can be used for the distal side. In some embodiments,the diameters (or other cross-sectional dimensions) of the braid fibersvary from about 0.005 inches to about 0.010 inches. However, inalternative embodiments, such diameters or other cross-sectionaldimension is less than about 0.005 inches or greater than 0.010 inches,as desired or required. In some embodiments, the expandable collectionmember 292 comprises two or more layers of braid material. In someembodiments, the proximal portion and the distal portion of the braidedcollection member 292 can be ultrasonically welded or otherwise attachedto form a regular smooth continuous rim and the removal member 294 isnot included.

In embodiments where elastomeric material is used for the expandablecollection member 292, the expandable collection member 292 can bemolded in a transfer press, an injection molding press, a compressionmolding press, a thermoforming press and/or using any othermanufacturing device, system or method.

IV. Alternate Modes of Expansion

In some embodiments, the collection member 134 (e.g., scaffold) cancomprise one or more shape memory or other materials that automaticallyexpand from a compressed configuration maintained during insertion ofthe endotracheal tube cleaning device 120 by a sheath to an expandedconfiguration when the sheath is withdrawn or the collection member 134is pushed out of the sheath. The shape memory material can includenickel titanium alloys and/or other shape memory materials. In someembodiments, the shape memory material can be temperature-activated,light-activated, and/or activated by liquid. In some embodiments, anexpandable removal member (e.g., O-ring) adhered to the outer or innersurface of the collection member 134 can automatically expand uponadvancement out of a sheath.

For example, FIGS. 30A-30C, 31A and 31B illustrate embodiments in whichthe collection member 134 (e.g., scaffold) is automatically expanded toan expanded configuration when a sheath is withdrawn or the collectionmember 134 is pushed out of the sheath. FIGS. 30A-30C illustrate anembodiment of a cleaning device 3020 that comprises a mesh collectionmember 3034 that is expanded by a spiral spring 3005 or other expandablemember that automatically expands when not constrained by a sheath 3015.FIG. 30A is a perspective view of the cleaning device 3020. FIGS. 30Band 30C illustrate the spiral spring 3005 of the cleaning device 3020 ina collapsed state and an expanded state, respectively.

In some embodiments, the distal end of the mesh collection member 3034is adhered to a distal cap and the proximal end of the mesh collectionmember 3034 is adhered to the steel spiral spring 3005. In use, thespiral spring 3005 is initially collapsed and inserted into the sheath3015. Then, the cleaning device 3020 is inserted within the endotrachealtube and advanced to a desired depth. Once the cleaning member has beenproperly inserted into the endotracheal tube, the sheath 3015 can bewithdrawn toward the actuation assembly 124, thereby allowing the spiralspring 3005 or other expandable member to expand, generally to the sizeof the endotracheal tube. In one embodiment, the expansion of the spiralspring 3005 causes expansion of the mesh collection member 3034. Thecleaning device 3020 can be subsequently withdrawn from the endotrachealtube while the mesh collection member 3034 captures at least a portionof the removed biofilm.

FIGS. 31A and 31B illustrate an embodiment of a cleaning device 3120having a shuttlecock-like collection member 3134. FIG. 31A illustratesthe shuttlecock-like collection member in its compressed state, whileFIG. 31B illustrates the shuttlecock-like collection member in itsexpanded state. In some embodiments, the shuttlecock-like collectionmember 3134 comprises material that automatically expands to about thediameter of the endotracheal tube when not constrained by a sheath 3115.In one embodiment, the distal end of the shuttlecock-like collectionmember 3134 is adhered to a distal cap and the proximal end of thecollection member 3134 is left unattached. In use, the shuttlecock-likecollection member 3134 can be initially collapsed and fed into thesheath. Then, the cleaning device 3120 can be inserted within theendotracheal tube. Once the cleaning member 126 is inserted to itsproper depth, the sheath can be withdrawn (e.g., retracted toward theactuation assembly 124), thereby allowing the shuttlecock-likecollection member 3134 to expand to the size of the endotracheal tube.In some embodiments, the cleaning device 3120 is withdrawn from theendotracheal tube while the shuttlecock-like collection member 3134collects at least a portion of the removed biofilm.

In other embodiments, the collection member 134 can be expanded usinginflation. For example, the removal member 132 can comprise aninflatable O-ring, which when inflated, causes the collection member 134to expand. The inflatable O-ring can be on the inside of the collectionmember 134 (e.g., similar to an innertube) or on the outside of thecollection member 134. In some embodiments, an inflatable balloon orother member is configured to selectively expand the cleaning member 126and/or any other portion of the cleaning device. In one embodiment, theremoval member comprises a smooth or textured inflatable balloon orbladder.

V. Controlled Expansion

In some embodiments, the endotracheal tube cleaning device 120 canprovide for variable expansion of the cleaning member 126, depending onthe tube's inside diameter, the amount of biofilm deposited on theinternal surface of the endotracheal tube 100 and/or one or more otherfactors or considerations. In other embodiments, the endotracheal tubecleaning device 120 can selectively deploy the cleaning member 126 withvariable pressure depending on the endotracheal tube's inside diameter,the amount of biofilm deposited on the internal surface of theendotracheal tube 100 and/or one or more other factors orconsiderations. In some embodiments, the actuation assembly 124 isconfigured to expand the cleaning member 126 about 0.1 mm to about 2 mmlarger than the inside diameter of the endotracheal tube (e.g., fromabout 0.1 mm to about 1 mm, about 0.5 mm to about 1.5 mm, about 1 mm toabout 2 mm, and overlapping ranges thereof).

In some embodiments, the actuation assembly 124 includes features thatprovide for incremental expansion of the cleaning member 126. FIG. 20illustrates an assembled actuation assembly 124 configured to providecontrolled, incremental expansion of the cleaning member 126. FIGS.21A-21D illustrate various perspective views of components of oneembodiment of an actuation assembly 124. For example, FIGS. 21A and 21Billustrate a detent half 312 and FIG. 21C illustrates a thumb handlehalf 314 of the handle 150. As shown in FIG. 21A, the detent half 312can include multiple detents 315 incrementally spaced along its length.The detents 315 can be formed as notches, slits, recesses, and/or thelike within the molded material of the detent half 312. The detents canbe used to set a specific pressure and/or outer diameter of the expandedcleaning member. As shown in FIG. 21B, the detent half 312 can includevisible markings or indicia 313. The visible markings can aid theclinician in setting the initial position of the trigger 152 withrespect to the handle 150 depending on the diameter of the endotrachealtube to be cleaned. The visible markings 313 can also provide visiblefeedback to the clinician as to what diameter the cleaning member iscurrently expanded to. The visible markings can include color or patternvariations, text, varying line sizes or widths, numbers, and/or thelike. In some embodiments, the visible markings provide tactile feedbackto the clinician.

FIG. 21D illustrates one embodiment of a trigger 152 for an actuationassembly. As shown, the trigger 152 can include one or more bumps,ridges, projections 316 and/or the like. In some embodiments, the bump316 is sized, shaped, or otherwise adapted to engage with, or be atleast partially received by, the detents 315 of the handle 150. In someembodiments, the trigger 152 includes multiple bumps 316 or similarfeatures. The trigger 152 can be captured by the assembly of the handlehalves 312, 314. Further, the handle halves 312, 314 can be coupled toeach other or otherwise assembled using adhesives, crush ribs, snap fitconnections, other mechanical fasteners, ultrasonic welding, and/or anyother suitable attachment method or device.

The detents 315 can serve to provide a hard stop and gauge for the sizeof the endotracheal tube being to be cleaned. Accordingly, a singlecleaning device can be used to clean endotracheal tubes having any of arange of inner diameters. For example, and not by way of limitation, thedetents 315 can allow for cleaning of endotracheal tubes having an innerdiameter between about 5 mm and about 10 mm. In other embodiments, thedetents 315 can permit for cleaning of endotracheal tubes (or any othermedical or non-medical tube) with inner diameter below 5 mm or above 10mm, as desired or required. The detents 315 can be spaced to provide forincremental expansion in 0.5 mm or 1 mm increments. However, any otherincremental expansion may be used. Engaging the appropriate detent foreach endotracheal tube size can advantageously allow for the appropriateamount of scaffold deployment based on the inner diameter of theendotracheal tube. The detents 315 can comprise bumps or otherprotruding members to provide a tactile and/or an audible gauge orconfirmation. The bumps along with suitable markings can allow theclinician to determine the inner diameter of the endotracheal tube.

The detent and bump profiles can be modified for smooth operation andreentry. For example, the edges and tips of the detents 315 can beradiused such that the bumps 316 do not hang up or otherwise serve as anobstruction. In some embodiments, the edges and tips of the detents 315are generally smooth in order to reduce friction. In some embodiments,the handle 150 can include visible indicia on the outside surface toindicate the correspondence between the detents 315 and the innerdiameter dimensions. Accordingly, a clinician can make sure that thecleaning member 126 is appropriately expanded for the particularendotracheal tube being cleaned. In some embodiments, the radiusing ofthe detent tips and slight play in the trigger 152 allows for “finetuning” of the expansion during removal of the endotracheal tubecleaning device 120.

In other embodiments, the actuation assembly 124 can be configured toprovide for continuous controlled expansion of the cleaning member 126,such as a rotatable thumbwheel assembly 3200, as shown, for example, inFIG. 32. The handle of the rotatable thumbwheel assembly 3200 can berotated to incrementally expand the cleaning member 126 in a controlledmanner.

Under some circumstances, the failure to contact the biofilm or insidewall of the endotracheal tube with the appropriate pressure canpotentially result in invagination or cavitation. Accordingly, in someembodiments, the endotracheal tube cleaning device 120 is configured toallow for manual fine tuning or adjustment of the expansion of thecleaning member 126. In some embodiments, the clinician can adjust theexpansion of the cleaning member 126 based upon an actual or estimatedbiofilm thickness (e.g., maximum biofilm thickness, average biofilmthickness, etc.) within the endotracheal tube 100 and the known innerdiameter of the endotracheal tube 100. For example, the estimatedmaximum biofilm thickness can be determined based on the endotrachealtube length, the inner diameter of the endotracheal tube, the reason forventilation, one or more patient risk factors, the amount of biofilmremoved at particular time intervals (e.g., 3, 8, 12, 24 hours, othertime intervals, etc.).

In other embodiments, the clinician can adjust the expansion of thecleaning member based on, at least in part, a pressure sensor of theendotracheal tube cleaning device 120, tactile feedback, visualizationof the biofilm using a visualization scope and/or one or more otherfactors or indicators.

In embodiments wherein a pressure sensor is used, the pressure sensorcan be an electrical or nanotechnology sensor configured to sense theoptimal pressure against the wall of the endotracheal tube 100. Thus,the clinician can selectively adjust the expansion of the cleaningmember 126 based upon the measured pressure and/or one or more otherinputs. In other embodiments, the pressure sensor can be connected to afeedback mechanism to provide for automatic adjustment (e.g., expansionor contraction) of the cleaning member.

In some embodiments that incorporate visualization, expansion of thecleaning member can be manually or automatically set or adjusted basedon an analysis of the diameter of the endotracheal tube 100, the amountof biofilm 116 present in the endotracheal tube 100 and/or one or moreother factors or considerations.

In some embodiments, the removal member 132 comprises one or morematerials that automatically expand to independently apply pressure tothe wall of the endotracheal tube, thereby providing automatic“fine-tuning” of the extent of expansion after a “rough” mechanicalexpansion of the actuation assembly 124 and the collection member 134.

VI. Depth Control

The endotracheal tube cleaning device 120 can include featuresconfigured to control the depth of insertion of the endotracheal tubecleaning device 120 within the endotracheal tube 100. In someembodiments, the endotracheal tube cleaning device 120 includes visibleindicia along the length of the outer shaft 129 to indicate the depth ofthe endotracheal tube cleaning device 120 in the endotracheal tube 120.In some embodiments, a lockable, movable stop is coupled to the outershaft 129 to prevent against over-insertion of the endotracheal tubecleaning device 120 beyond the distal tip 108 of the endotracheal tube100. In other embodiments, the endotracheal tube cleaning device 120includes a visualization channel or lumen in which a visualization scopecan be inserted to determine the exact positioning of the endotrachealtube cleaning device 120 within the endotracheal tube 100. In stillother embodiments, radiopaque markers can be used in combination withimaging modalities to determine the depth of insertion.

A. Mechanical Control

FIG. 22 illustrates an embodiment of the endotracheal tube cleaningdevice 120 having a movable stop 322 and visible depth markings 323. Insome embodiments, the visible depth markings 323 can be configured toalign with corresponding depth measurements on the outside of theendotracheal tube 100. For example, if the endotracheal tube cleaningdevice 120 is being inserted into an endotracheal tube having a lengthof 26 cm, the endotracheal tube cleaning device 120 can be inserteduntil the 26 cm mark on the endotracheal tube cleaning device 120 isaligned with the 26 cm mark on the endotracheal tube. The visible depthmarkings 323 can be calculated such that when the corresponding depthmarks are aligned, the distal tip of the endotracheal tube cleaningdevice 120 is at the desired depth within the endotracheal tube 100(e.g., 1.5 cm proximal of the distal tip 108). Once the visible depthmarkings 323 are aligned with the corresponding markings on theendotracheal tube, the movable stop 322 can be locked in place at theproximal end 102 of the endotracheal tube 104, thereby providing apositive check on the insertion of the endotracheal tube cleaning device120 within the endotracheal tube 100 and advantageously preventingagainst or reducing the likelihood of inadvertent over-insertion.

FIGS. 23A-23E illustrate various alternative embodiments of a movablestop 322 configured for use with an endotracheal tube cleaning device.FIG. 23A illustrates a locking clip design 330. In the unlockedconfiguration (shown in FIG. 23A), the locking clip can slide freelyalong the length of the outer shaft 129. When the locking clip is movedto the correct position, as determined by the visible depth markings323, the locking clip can be squeezed or otherwise manipulated toactuate the living hinge feature and engage the locking feature.Accordingly, the locking clip can be maintained in a fixed position. Thelocking clip design 330 advantageously provides one-handed operation, aone-piece design, and a secure fastening feature. The materials for thelocking clip design can comprise materials capable of providing “livinghinge” capability, such as, for example, nylon, polypropylene,polycarbonate, and/or the like. In some embodiments the materials forthe locking clip design 330 can comprise flexible materials, such as,for example, urethane, silicone, and/or the like.

FIG. 23B illustrates an internal oval design 331. The internal ovaldesign 331 provides a constant “lock” due to the interference of theinternal oval opening with the radius of the outer shaft 129. In someembodiments, in order to temporarily “unlock” the movable stop and movethe internal oval stop, manual force is used to overcome the frictionfit connection of the internal oval design 331. The internal oval of theinternal oval design 331 can become substantially circular as it ismoved along the outer shaft 129. Once in position, the internal oval canreturn to a substantially oval shape. In some embodiments, the internaloval design 331 advantageously provides one-handed operation, aone-piece design, and a secure fastening feature. The materials for theinternal oval design 331 can comprise materials having desired orrequired physical and other properties, such as, for example, toughness,flexibility, short term creep resistance, and/or the like. Suchmaterials can include, for example, urethane, polyisoprene, TPE, otherpolymeric or elastomeric materials and/or the like.

FIG. 23C illustrates one embodiment of a spring lock design 332 that issimilar to the locking clips used on sweatshirt strings or drawstringbags. The bore or aperture 333 of the illustrated spring lock can have adiameter slightly larger than the diameter of the outer shaft 129. Thespring lock is maintained in a locking position by a spring-loadedfeature. According to some embodiments, in order to unlock the device tomove to a new position, the spring-loaded feature is compressed bypressing on the compression element 334. When the spring lock ispositioned in the desired position, the compression element 334 can bereleased, thereby releasing the spring-loaded feature to re-lock thespring lock. In other embodiments, the cylindrical features of thespring lock design 332 can be substituted with flat, rectangularfeatures. In some embodiments, the spring lock design 332 advantageouslyprovides one-handed operation. The spring lock design 332 can compriseone or more materials including, but not limited to, ABS, polypropylene,nylon, filled polypropylene, polycarbonate, polyethylene, other suitableinjection-moldable grade resins, other polymeric or elastomericmaterials, and/or the like.

FIG. 23D illustrates one embodiment of a double wing design 335. Thedouble wing design 335 includes a D-shaped opening 336 and twosymmetrical wings 337. In some embodiments, the flat-section of theD-shaped opening 336 is configured to match a corresponding flat sectionof the cross-section of the outer shaft 129. When the corresponding flatsections are aligned, the double wing stop can move freely along theouter shaft 129. In one embodiment, in order to set the maximum depth,the double wing stop is turned either clockwise or counterclockwiseusing the wings 337 so that the flat section of the D-shaped opening 336interferes with the radius of the outer shaft 129. The double wingdesign 335 can advantageously provide one-handed operation and aone-piece design. The double wing design 332 can comprise one or morematerials such as, for example, ABS, polypropylene, nylon, filledpolypropylene, polycarbonate, polyethylene, other suitableinjection-moldable grade resins, other polymeric or elastomericmaterials, and/or the like.

FIG. 23E illustrates one embodiment of an oval design 338. According tosome embodiments, the oval design 338 includes a D-shaped opening 339and operates in a similar manner to the double wing design 335. The ovaldesign 338 can advantageously provide one-handed operation and aone-piece design. The oval design 338 can comprise one or more materialssuch as, for example, ABS, polypropylene, nylon, filled polypropylene,polycarbonate, polyethylene, other suitable injection-moldable graderesins, other polymeric or elastomeric materials, and/or the like.

In some embodiments, an elastomeric bag can be attached to the movablestop 322 for containment of the collected biofilm after removal from theendotracheal tube 100. The elastomeric bag can be attached in a furledor rolled-up configuration. The movable stop 322 with the attachedelastomeric bag can be moved along the outer shaft 129 in proximity tothe biofilm that has been collected on the cleaning member 126. Theelastomeric bag can then be rolled out, or unfurled, over the cleaningmember 126, thereby containing the collected biofilm until it has beensafely deposited into a biohazardous container. The elastomeric bag cancomprise one or more materials, such as silicone, latex, otherelastomeric or polymeric materials, and/or the like.

B. Visualization

According to some embodiments, mechanical depth control can be enhanced,supplemented, or replaced with the help of one or more visualizationfeatures. As described above, an endotracheal tube cleaning device 120can include a visualization channel or lumen configured to receive avisualization element (e.g., visualization scope 142). The visualizationelement can utilize ultrasound, infrared, CCD, fiber optic and/or anyother type of imaging technology. For example, the visualization scopecan comprise a fiber optic camera on the end of an endoscope. Asdiscussed herein, the distal tip 130 of the endotracheal tube cleaningdevice 120 can include a transparent viewing “window” and/or otherviewing area or region. The transparent viewing window or area of thevisualization channel can advantageously enable a clinician to positionthe distal tip 130 of the endotracheal tube cleaning device at aselected location with respect to the endotracheal tube 100. The windowcan advantageously have a thickness of less than about 0.010 inches (forexample, 0.001 inches, 0.002 inches, 0.003 inches, 0.004 inches, 0.005inches, 0.006 inches, 0.007 inches, 0.008 inches, 0.009 inches). Thelens of the visualization scope can be indented by a few thousandths ofan inch (e.g., 0.001 to 0.004 inches) in order to prevent or reduce thelikelihood of scratches and damage to the lens. In some embodiments, thewindow thickness combined with the lens indentation is less than about0.010 inches. This can help reduce glare and/or halo effects and canotherwise improve the quality of visualization. This can provideenhanced visualization to a clinician or other user as glare can make itdifficult to view anatomical features. However, in other embodiments,other distances and/or thicknesses are used, as desired and/or required.One or more antireflective coatings, layers or features can be appliedto the outside and/or inside of the window to further reduce glare.

In some embodiments, the proximal end of the visualization channel isconstructed with a introducer sheath area suitable for preventing orreducing the likelihood of contamination of the visualization element,thereby enabling reuse of the visualization element from one patient toanother without concern for cross-contamination.

In some embodiments, the visualization element can facilitate, optimize,and/or document the endotracheal tube cleaning procedures. In someembodiments, the images received from the visualization element scopecan be transferred to remote locations over a network, as describedabove, to permit remote observation. In some embodiments, anendotracheal tube cleaning system comprises a visualization scope (e.g.,endoscope with a fiber optic camera), an external camera for viewing thenurse and the patient from a control room outside the ICU environment.The images from the visualization scope and external camera can betransmitted, along with clinical test and/or patient data, such asoxygen saturation, heart rate, respiration rate, and/or the like, tofacilitate the remote treatment of the ICU patient.

With reference to FIG. 33A, the endotracheal tube cleaning device 120can comprise a scope retention assembly 3325 configured to exert astatic backward force on a visualization scope 3342 inserted within avisualization channel of the endotracheal tube cleaning device 120. Thescope retention assembly 3325 can comprise a stretchable elastomericsheath 3305 and a scope retention member 3315. The elastomeric sheath3305 can be attached to the actuation assembly 124 at its distal end (asshown best in FIG. 33C) and to the scope retention member 3315 at itsproximal end. In some embodiments, the elastomeric sheath 3305 isadvantageously coupled to the actuation assembly 124 in such a manner soas not to disrupt the operation of the actuation assembly 124.

In some embodiments, the elastomeric sheath 3305 comprises a stretchablematerial that can be stretched so that corresponding retention featuresof the scope retention member 3315 and of the visualization scope 3342inserted within the elastomeric sheath 3305 interact to provide abackward static force. As described in greater detail herein, such afeature can cause the distal lens end of the visualization scope 3342 tobe pressed against a window at the distal end of a visualizationchannel. For example, as shown in FIG. 33A, a stationary locking ring3330 on the visualization scope 3342 can be received within a groove orslot in the scope retention member 3315.

FIG. 33B illustrates a cross-sectional view of the proximal end of theendotracheal tube cleaning device 3320 and a visualization channel 3335extending through the actuation assembly 124 and into the elongate body122 of the endotracheal tube cleaning device 3320. FIG. 33C illustratesa close-up view of the connection between the elastomeric sheath 3305and the actuation assembly 124. As shown, the distal end of theelastomeric sheath 3305 is adhered, attached or otherwise coupled to abarb attachment 3340 of the trigger 152 of the actuation assembly 124.The elastomeric sheath 3305 can be adhered to the actuation assembly 124using one or more mechanical fasteners (e.g. low profile clip, othertypes of clips, etc.), adhesives, and/or other coupling device ormethod, including, for example, interference fits, ultrasonic welding,UV cure adhesives, epoxy, and/or the like. Although the endotrachealtube cleaning device and the sleeve are disposable in many embodiments,the elastomeric sheath, according to one embodiment, is or comprises adetachable disposable portion, while other portions of the endotrachealtube cleaning device remain reusable.

With reference to FIG. 33D, the visualization scope 3342 can comprise ascope retainer sleeve 3350 that fits over the visualization scope 3342.The scope retainer sleeve 3350 can be permanently or temporarily adheredor otherwise coupled to the visualization scope 3342. In one embodiment,the scope retainer sleeve 3350 comprises a stationary locking ring 3330or other retention feature that is positioned on the visualization scope3342 at a predetermined distance from the distal end of thevisualization scope 3342 (e.g., approximately 25 inches, less than 25inches, more than 25 inches, etc.). The predetermined distance can beselected based on the length of the visualization channel 3335 of theendotracheal tube cleaning device 3320, the length of the scoperetention assembly 3325 and/or any other factors or considerations.

FIG. 33E illustrates a cross-sectional view of the actuation assembly ofFIG. 5B. As shown, the visualization channel 3335 can be entirelyaligned with the longitudinal axis of the main elongate body 122 of theendotracheal tube cleaning device by providing an actuation assemblyhaving an offset thumb grip 153. By inserting the visualization scopealong the longitudinal axis of the elongate body through a flared“trumpet-like” or substantially conical opening 3355 at the proximal endof the actuation assembly, kinking of the visualization scope can beadvantageously prevented or minimized. In some embodiments, thevisualization channel 3335 can have varying cross-sectional dimensionsalong its length. For example, the visualization channel 3335 can haveone or more radial transitions for the visualization scope.

FIGS. 33F and 33G illustrate the interaction between the scope retentionassembly 3325 and the visualization scope 3342 to create the staticbackward force on the visualization scope 3342. FIG. 33F illustrates thescope retention assembly 3325 and the visualization scope 3342 beforeloading, while FIG. 33G illustrates the scope retention assembly 3325and the visualization scope 3342 after loading. In some embodiments, theelastomeric sheath 3305 can be stretched such that a correspondingreceiving slot of the scope retention member 3315 is aligned and matedwith the stationary locking ring 3330 of the scope retainer sleeve 3350on the visualization scope 3342 and then released to exert the backwardstatic force due to the return force provided by the elastomericcharacteristics of the elastomeric sheath 3305. In some embodiments, theelastomeric sheath 3305 can be stretched up to one inch or more (e.g., ¼inch, ½ inch, 1 inch, 1½ inches, 2 inches, 3 inches, more than 3 inches,etc.) from its relaxed, non-stretched state without requiring anexcessive amount of pull force. However, in other embodiments, thesleeve can only be stretched to a distance of less than 1 inch. In someembodiments, the sleeve comprises one or more bellows, expansion zonesor members and/or other features that are configured to stretch orexpand, either in addition to or in lieu of the materials. The backwardforce that results can advantageously press the lens end of thevisualization scope 3342 against the window at the distal end of thevisualization channel 3335, thereby reducing glare, improving thequality of visualization and providing one or more other benefits to theclinician.

FIGS. 34A, 34B, 35A, and 35B illustrate two embodiments of the scoperetention member 3315. FIGS. 34A and 34B illustrate a perspective viewand a cross-sectional view, respectively, of a “Slide” embodiment of thescope retention member 3315, and FIGS. 35A and 35B illustrate aperspective view and a cross-sectional view, respectively, of a “Snap”embodiment of the scope retention member 3315.

In the “Slide” embodiment of a scope retention member 3415 shown inFIGS. 34A and 34B, the scope retention member 3415 comprises a C-shapedproximal end 3402, a substantially hollow body 3404, and a substantiallycylindrical distal end 3406. In some embodiments, the body 3404comprises ridges, grooves, or other surface features 3408 (e.g., toimprove gripping). In some embodiments, the visualization scope 3342 isreceived coaxially within the scope retention member 3415. In order toprovide the backward force on the visualization scope 3342, the scoperetention member 3415 is advanced (while stretching the elastomericsheath 3305) until the lower surface of the C-shaped proximal end 3402is proximal to the stationary locking ring or circumferential protrusion3330 disposed on the visualization scope 3342. The side slot 3412 of theC-shaped proximal end 3402 is then slid over the ring 3330 such that thering 3330 abuts against the lower surface of the C-shaped proximal end3402. In some embodiments, the lower surface of the C-shaped proximalend 3402 includes a groove or recess that receives the ring 3330 or anannular ridge disposed on the upper surface of the ring 3330 to furthersecure the ring 3330 within the scope retention member. In oneembodiment, the side slot 3412 comprises a pair of hemisphericalprotuberances or ridges (not shown) extending towards each other onopposite sides of the side slot 3312 to aid in retention of thevisualization scope 3342 within the side slot 3412. In some embodiments,the C-shaped proximal end comprises a shape that is not necessarilyC-shaped but still has the side slot 3412. In some embodiments, thesubstantially cylindrical distal end 3406 comprises a non-cylindricalshape.

In the “Snap” embodiment of a scope retention member 3515 shown in FIGS.35A and 35B, the scope retention member 3515 comprises a generallycylindrical distal end 3502 and an outwardly-tapered receiving sleeve3504 at its proximal end. The receiving sleeve 3504, for example, cancomprise a collet-like assembly of two or more leaflets or fingers. Asshown in the perspective view of FIG. 35A, the proximal end comprisesfour leaflets or fingers. With reference to the cross-sectional view ofFIG. 35B, the leaflets or fingers are substantially cored out or atleast partially hollowed such that the ring or circumferentialprotrusion 3330 disposed on the visualization scope 3342 can be receivedwithin the scope retention member 3515. As the elastomeric sheath 3305with the scope retention member 3515 is pulled over the stationarylocking ring 3330 of the visualization scope 3342, the leaflets of thescope retention member 3515 bend out of the way to allow the ring tomove through and then seat in place in abutment against the lowersurfaces of the wedged heads 3506 of the leaflets. The general shape andgeometry of the scope retention member 3515 can vary without departingfrom the spirit and/or scope of the disclosure.

Other designs and approaches of creating a static reverse force on thevisualization scope to improve the quality of visualization are possiblewithout departing from the spirit and/or scope of the disclosure herein.

VII. Supplementary and Preventative Modalities/Capabilities

In some embodiments, the endotracheal tube cleaning device 120 can haveone or more channels or lumens for visualization, aspiration or suction,ventilation, irrigation/infusion, light delivery, and/or the like. Insome embodiments, the endotracheal tube cleaning device 120 can have asingle channel (e.g., a central lumen) for insertion of multiplecatheters, probes, scopes, and/or other instruments. In otherembodiments, the endotracheal tube cleaning device 120 includes two ormore channels. For instance, an endotracheal tube cleaning device 120can comprise a visualization channel, a suction channel, and anirrigation/infusion channel.

In arrangements including a side port 140, one or more channels orlumens of the endotracheal tube cleaning device 120 can be incommunication with such a side port 140. In some embodiments, thechannels or lumens of the cleaning device can be sheathed to preventcontamination of the catheters, probes, scopes, and/or other instrumentsinserted therein.

The additional catheters, probes, scopes, and/or instruments providingadditional features to supplement and/or facilitate the cleaning of theendotracheal tube can be configured for single-handed operation. Thesingle-handed operation can be facilitated with the use of fibers,cables, conduits, and/or lines of sufficient length such that the bulkycomponents of the additional diagnostic, visualization, and/ortherapeutic instruments or systems are positioned remote from thepatient. In some embodiment, user controls for the additionalinstruments or systems are located adjacent to the patient or adjacentto the actuation assembly 124 of the endotracheal tube cleaning device120 to enable the single-handed operation by the user. The variousmechanisms can be controlled by pressing one or more user input controlswith a single finger. In some embodiments, a different finger can beused for each respective action (e.g., one finger for aspiration andanother finger on the same hand for irrigation or drug delivery). Inother embodiments, the additional instruments and/or capabilities can becontrolled by multiple hands and/or multiple persons.

In some embodiments, the additional instruments and capabilities can becontrolled by the clinician concurrently with cleaning of theendotracheal tube with the endotracheal tube cleaning device 120. Inother embodiments, the additional instruments and capabilities can beactivated before, concurrently with, and/or after the cleaning with theendotracheal tube cleaning device 120. In some embodiments, two or moreinstruments can be activated simultaneously (for example, forbroncho-alveolar lavage).

A. Suction/Aspiration

In some embodiments, a suction or aspiration catheter, conduit, or linecan be inserted into a channel of the endotracheal tube cleaning device120. The suction catheter can be used to perform an initial pre-cleaningsuctioning of the tracheobronchial tree, the endotracheal tube 100and/or any other item or region of the anatomy. The suction catheter canalso be used to aspirate biofilm removed by the cleaning member 126 ofthe endotracheal tube cleaning device 120. The aspiration catheter canbe used for sampling and analysis of the biofilm within the endotrachealtube of a patient to determine the bacterial content or nature of thebiofilm. The clinician can then implement more effective treatment,antibiotics and safeguards against cross-contamination based at least inpart on the determination of the bacterial content, therebyadvantageously reducing infections, conditions, and/or other ailments,including but not limited to VAP, and reducing the length of stay of theICU patient. In some embodiments, the endotracheal tube cleaning device120 has a proximal seal at the entry of the tube for generally sealingthe region during the application of suction, thereby helping to enhancethe removal of material.

In some embodiments, the removal member 132 (e.g., O-ring) can includeone or more openings or ports spaced continuously or intermittentlyaround its circumference or other outer region to facilitate in theaspiration of biofilm and/or other materials. The suction catheter,conduit, or line can provide suction to the removal member 132 tofacilitate removal of small amounts of biofilm that are not completelyremoved (e.g., wiped) from the inside surface of the endotracheal tube100.

B. Irrigation/Fluid Delivery

In some embodiments, a delivery catheter can be inserted into a channelof the endotracheal tube cleaning device 120. Accordingly, the deliverycatheter can be used to selectively deliver one or more fluids and/orother materials to a target region. In some embodiments, such fluidsand/or other materials are adapted to disinfect, decontaminate, orsterilize the endotracheal tube. In some embodiments, such fluids and/orother materials are configured to loosen, break up, penetrate, degrade,disperse, dissolve and/or otherwise undermine or affect the biofilm 116deposited on the inside surface of the endotracheal tube 100. In someembodiments, such fluids and/or other materials can aid in removal ofthe biofilm 116 and/or aid in the prevention of the future accumulationof biofilm. The delivery catheter can be configured and positioned todeliver one or more fluids and/or other materials to the inside wall ofthe endotracheal tube 100, tracheobronchial tree and/or any other regionwithin a person's anatomy.

In some embodiments, fluids and/or other materials that are selectivelydelivered through a channel or lumen of the cleaning device include,without limitation: medicaments, biologically active agents,antibacterial or antimicrobial agents, bactericides, antiviral agents,mucolytic agents, saline solution, sterilant, enzymatic cleaner,germicide, antimicrobial fluid, detergent, combinations of the same,and/or the like. In some embodiments, the antiviral agents can beconfigured to prevent or treat ventilator assisted pneumonia or othermaladies or conditions. Ultraviolet, germicidal and/or antimicrobialtreatment may be incorporated in several embodiments. Therapeuticmodalities are included in some embodiments, including but not limitedto, radiofrequency, ultrasound, laser, microwave, heat, and cryotherapy,or combinations thereof. In one embodiment, the therapy is used toeffect fibrosis, stiffening and/or ablation.

In some embodiments, an irrigation channel or lumen can deliver drugs,fluids and/or other materials via the removal member 132 (e.g., O-ring),the collection member 134 (e.g., mesh scaffold), a deployment member(e.g., struts) and/or any other component or portion of the cleaningdevice. In some embodiments, the irrigation channel or lumen includesmultiple outlets that are in communication with the outside of theendotracheal tube cleaning device 120 along the length of the channel.Accordingly, such embodiments can be used to selectively deliver fluidsand/or other materials (e.g., antibiotics, antiviral substances, otherpharmaceuticals, antiseptics, therapeutic agents, and/or the like) tothe biofilm 116. In other embodiments, the irrigation channel or lumenincludes a single outlet, either at the distal end of the endotrachealtube cleaning device 120 (e.g., in the distal tip 130) or at any otherlocation along the length of the device, in order to selectively deliverthe desired fluids, agents, and/or other materials to the biofilm 116.The one or more outlets can comprise a one-way valve, slit, and/ordiaphragm to substantially seal the outlet, thereby preventing orreducing the likelihood of contamination due to an influx of bacteria ormaterials from inside the patient.

In some embodiments, an irrigation channel or lumen can be used todeliver drugs in a spray pattern that will deliver the drugs in anacceptable amount or rate to the wall of the endotracheal tube 100. Insome embodiments, a drug delivery catheter can deliver a “mist” of aprescribed amount of a therapeutic agent, other pharmaceutical or drugand/or other substance to at least partially coat the inside wall of theendotracheal tube 100 and/or the biofilm attached thereto. In someembodiments, a drug delivery catheter can include a diffusing tip toenhance the spray of drugs to the wall of the endotracheal tube 100. Forexample, such tips or nozzles can help to more evenly diffuse thematerials along a target region of the endotracheal tube or biofilmlayer.

In other embodiments, an irrigation channel has a distal outlet directedat the “window,” or distal tip, of the visualization channel to helpclear debris and other materials away from the viewing window.Accordingly, the visualization features described herein can beimproved.

C. Ventilation

In some embodiments, the endotracheal tube cleaning device 120 has aninternal lumen that facilitates or enables the continued delivery ofair, pure oxygen and/or other gases to the patient while theendotracheal tube cleaning device 120 is in place. This can help ensurethat the patient's blood oxygen level is maintained above a thresholdlevel during a particular procedure. However, in other embodiments, thecleaning device does not require supplemental oxygen or other gases tobe delivered to a patient during a procedure. In some embodiments, thedelivered gas or gases can be heated to a temperature of between about120 degrees to about 180 degrees Fahrenheit.

D. Other Therapeutic Modalities

In some embodiments, one or more channels of the endotracheal tubecleaning device 120 can be used to deliver therapeutic modalities, suchas sonication, vibration, radiation, photodynamic therapy, light,electrical stimulation and/or the like.

For example, photodynamic therapy can be used to treat specific bacteriaidentified as being present within the endotracheal tube 100 or withinthe tracheobronchial tree. In some embodiments, one or more drugs can bedelivered through a channel (e.g., a drug delivery or infusion channel)of the endotracheal tube cleaning device 120 or by a separate drugdelivery catheter to the inner wall of the endotracheal tube. Then, oneor more light delivery elements (e.g., LEDs, lasers) can be insertedwithin the same channel or a different channel to deliver light at anappropriate wavelength (e.g., visible, infrared, UV wavelengths) toactivate the one or more drugs delivered to the inner surface of theendotracheal tube. For example, UV-C light can reduce surface bacteriacount within a matter of seconds. In certain embodiments, the drugs andlight can be delivered concurrently. In embodiments where the light isdelivered through the distal tip 130, the distal tip can be configuredto disperse and/or diffuse the light (e.g., using a diffuser, adeflector, and/or the tissue optics properties of the tip itself) suchthat the appropriate wavelength, intensity, and/or quantity of light canbe delivered to activate a specific drug. A control unit can beprogrammed and/or controlled to vary the wavelength, intensity, pulsewidth and duty cycle (if pulsed light is used), exposure time, and/orthe like of the light.

As another example, sound waves can be delivered through using asonication device. Such sound waves can advantageously have aninhibiting effect on the sustainability and/or growth of biofilm.Vibrations produced by the sonication device can loosen the tenacious ormore adherent biofilm. In some embodiments, one or more sensors orelectrodes can be introduced on a probe or catheter to detect one ormore physiological conditions or parameters of the patient.

VIII. Introduction Connector

In some embodiments, an endotracheal tube cleaning system includes anadapter or introduction connector that advantageously enables thepatient to remain connected to a mechanical ventilator, therebymaintaining ventilator airflow, during cleaning of the endotrachealtube.

FIGS. 24A and 24B illustrate two embodiments of adapter configurationsto facilitate introduction of a tube cleaning device 120 in anendotracheal tube during a procedure. In some embodiments, the distalend of the adapter 340 is configured to removably couple (e.g., directlyor indirectly) to the proximal end 102 of the endotracheal tube 100after removal of the ventilator coupling element 114. In someembodiments, the distal end of the adapter 340 is sized and configuredto be inserted within the lumen 106 of the endotracheal tube 100 (asshown in FIG. 24A). In other embodiments, the distal end of the adapter340 is sized and configured to fit around the outside surface of theendotracheal tube 100 (as shown in FIG. 24B), thereby reducing thelikelihood of the cleaning member of the endotracheal tube cleaningdevice 120 being snagged on a ridge introduced by the thickness of theinserted adapter 340 during removal from the endotracheal tube 100.

In some embodiments, the adapter 340 includes a ventilation port 342 anda device insertion port 344. The ventilator coupling element 114 can becoupled to the ventilation port 342 for connection to the ventilator.The device insertion port 344 can be used to insert the endotrachealtube cleaning device 120 and/or other devices (e.g., catheters, probes,scopes). In one embodiment, the device insertion port 344 includes anelastomeric diaphragm 346 to help prevent loss of ventilator tidalvolume. The elastomeric diaphragm 346 can comprise a slit, a one-wayvalve and/or any other device or feature to substantially seal aroundthe inserted device. This can advantageously help prevent the escape ofventilator tidal volume. The elastomeric diaphragm 346 can comprise oneor more elastomeric materials, such as, for example, urethane, latex,silicone, other polymeric or elastomeric materials, and/or the like. Thethickness of the diaphragm 346 can range from about 0.002 inches toabout 0.030 inches. In some embodiments, the thickness of the diaphragm346 is about 0.005 inches to about 0.20 inches. However, in otherembodiments, the diaphragm thickness is greater than 0.030 inches orsmaller than 0.002 inches, as desired or required.

The device insertion port 344 can be sufficiently long such that theentire distal end of the endotracheal tube cleaning device 120 islocated proximal to the distal end of the adapter 340 when the adapter340 is removed. For example, the length of the device insertion port 344can range from about 30 cm to about 60 cm. The diameter of the deviceinsertion port 344 can range from about 4 mm to about 7 mm. The innerdiameter of the ventilation port can be sized to be slightly larger thanthe outer diameter of the ventilator coupling element 114. The length ofthe adapter 340 can range from about 4 cm to about 10 cm. Otherdimensions for the adapter 340 can be used as desired and/or required.

As shown in FIG. 24A, the adapter 340A can be Y-shaped, with theventilation port 342 located at the proximal end of the adapter and thedevice insertion port 344 extending from the side of the adapter at anacute angle. The embodiment of the adapter 340B illustrated in FIG. 24Bis generally T-shaped, with the device insertion port 344 located at theproximal end of the adapter 340B and the ventilation port 342 extendingfrom the side of the adapter 340B at a right angle. In otherembodiments, the adapter 340B can be Y-shaped, with the ventilation port342 extending from the side of the adapter 340B at an acute angle. Theadapter 340B of FIG. 24B advantageously provides a straight insertionpath for the endotracheal tube cleaning device 120 or other devices. Inother embodiments, the adapters 340 can have a different shape orconfiguration than discussed and illustrated herein.

The adapters 240 can include distance markings from the connection tothe proximal end of the endotracheal tube to the opening of the deviceinsertion port 344 to aid in positioning the endotracheal tube cleaningdevice 120 and the locking of the movable stop 322. In some embodiments,the distance from the endotracheal tube connection to the opening of thedevice insertion port can range from about 4 cm to about 8 cm; however,other lengths can be used as desired and/or required.

According to some embodiments, kits of adapters 340 can be provided toaccommodate endotracheal tubes having various diameters. The adapters340 can include markings indicating the tube diameter(s) for which theycan be used. In other embodiments, the adapters 340 compriseone-size-fits-all (or one-size-fits-most) adapters that can be used tofit endotracheal tubes of various diameters. For example, the adapter340B of FIG. 24B has three varying cross-sectional diameters so as toenable the adapter 340B to fit endotracheal tubes of three differentouter diameters (e.g., 7 mm, 8 mm, or 9 mm).

In some embodiments, adapters 340 can also be used to at least partiallycontain biofilm that has been removed by the cleaning member 126. Forexample, when an adapter 340 is disconnected from the endotracheal tube100 and ventilator, the distal end of the adapter can be slid over thecleaning member 126, thereby providing a protective covering over theremoved biofilm to prevent contamination.

IX. Use

A. General Use

As generally described herein, the endotracheal tube cleaning devicesand systems described herein can be used to clean endotracheal tubeswhile a patient is being supported by a ventilator connected to theendotracheal tube. This cleaning is useful for increasing the availablespace for airflow in the endotracheal tube and for reducing orpreventing the build up of materials that would otherwise constrictairflow through the endotracheal tube and potentially be a nidus forinfection.

FIG. 25 illustrates an embodiment of the endotracheal tube cleaningdevice 120 inserted within an endotracheal tube 100 within a nativeairway 500 of a patient. The endotracheal tube cleaning device 120 canadvantageously be used to clean the endotracheal tube 100 while theendotracheal tube 100 remains inside the patient.

B. Indications

According to some embodiments, an endotracheal tube cleaning device 120can be used for a variety of indications. For example, the endotrachealtube cleaning device 120 can be used for preventative indications, fordaily use indications, and/or for near total occlusion indications. Insome embodiments, the endotracheal tube cleaning device 120 can be usedat least once a day to prevent any extensive buildup of biofilm, asbiofilm has been shown to start building up as early as within 24 hoursof intubation. Daily utilization can coincide with ICU protocols fordaily extubation attempts for all patients. In other embodiments, thefrequency of endotracheal tube cleaning can vary, depending on patient,the patient's health and other conditions, a desired cleaning protocoland/or the like.

For example, in some embodiments, the endotracheal tube cleaning device120 can be used multiple times a day for high risk patients. High riskpatients can include older patients, smokers, patients with chronicobstructive pulmonary disease (COPD), patients intubated as part oftheir treatment for respiratory insufficiency related to pneumonia,patients with an indwelling endotracheal tube for longer than 24 to 48hours and/or others. The frequency of use can be determined by clinicalevaluation and observation of the degree of secretions being produced byan individual patient. However, the frequency of cleaning can depend onone or more other features, as desired or required.

The endotracheal tube cleaning device 120 can advantageously be used onintubated patients with ongoing bloody secretions or frank hemoptysis inorder to prevent clots from obstructing the endotracheal tube lumen. Theendotracheal tube cleaning device 120 can also be used on patients whofail weaning and extubation trials before tracheostomy is performed. Theendotracheal tube cleaning device 120 can advantageously be used onintubated patients who experience an acute unexplained change in theirrespiratory or ventilatory status in order to rule out mucous pluggingor clotting within the endotracheal tube as a cause of the suddendeterioration.

The amount of biofilm to be removed in the various indications can varygreatly. By way of example, for a prevention indication, theendotracheal tube cleaning device 120 can collect about 1 cc to about 5ccs of biofilm. By contrast, in daily use indications, the endotrachealtube cleaning device can collect about 5 ccs to about 15 ccs of biofilm.Further, for near total occlusion indications, the endotracheal tubecleaning device can collect more than about 15 ccs of biofilm.

In one embodiment, the cleaning member can be radially expanded orotherwise radially deployed in a manner that sufficient contacting forceis maintained between a contact surface of the cleaning member and theinternal wall of the endotracheal tube and/or the biofilm accumulatedthereon. This can advantageously permit the cleaning member to shear,wipe, or otherwise remove the biofilm, while preventing or reducing therisk of hydroplaning, cavitation, and/or invagination.

In several embodiments, the pull-out force used to withdraw theendotracheal tube cleaning devices can be provided by a clinician usinga single hand without significant strain. In one embodiment, thecleaning device comprises a mesh scaffold coupled to a silicone O-ringhaving a softness of 40 Shore A durometer with a pull-out force that iscomparable to the mesh scaffold alone. In one embodiment, the removalmembers do not appreciably increase the pull-out force used to withdrawthe endotracheal tube cleaning devices when such devices are being usedto remove biofilm deposited on the internal wall of an endotracheal tubein a single pass.

C. Cleaning Processes

FIG. 26 is a flow chart illustrating an embodiment of a process 2600 forcleaning an inside surface of an endotracheal tube (e.g., endotrachealtube 100) while such an endotracheal tube 100 is inserted within apatient. The cleaning process 2600 starts at block 2610, where the headof the bed is positioned at approximately 30° relative to horizontal. Inother embodiments, the head of the bed can be positioned at angleslarger or smaller than 30° relative to horizontal as desired and/orrequired. According to some embodiments, information related to thepatient's heart rate, heart rhythm, blood pressure, O₂ saturation, othervital signs and/or other desired data can be detected and advantageouslydisplayed to the clinician performing the cleaning procedure. In someembodiments, oxygen at 100% FiO₂ or nearly 100% FiO₂ is delivered to thepatient for ten minutes or another desired time period via a ventilatorattached to the patient's endotracheal tube 100, as illustrated at block2615. A disposable chux, pad and/or support member can be placed underthe endotracheal tube 100 and ventilation connection, and may be spreadout over the patient's chest.

Next, in some embodiments, routine endotracheal suction is performed,and the endotracheal tube 100 is checked to confirm that it is properlysecured to the patient's face and/or mouth, as illustrated at block2620. The exact length from the visible proximal end of the endotrachealtube 100 to its tip within the patient can then be determined fromvisible markings on the endotracheal tube 100, as illustrated at block2625. According to some embodiments, the endotracheal tube cleaningdevice 120 is visualized and the movable locking stop 322 that prohibitsover-insertion of the endotracheal tube cleaning device 120 is locked toan axial position that deploys the cleaning member 126 no closer than1.5 cm from the distal tip of the endotracheal tube 100, as illustratedat block 2630. In other embodiments, the movable stop on theendotracheal tube cleaning device 120 is set to the positioncorresponding to the length of the endotracheal tube.

In some embodiments, the ventilator is temporarily disconnected from theendotracheal tube 100 at block 2635 and the endotracheal tube cleaningdevice 120 is inserted into the endotracheal tube up to the locking stop322 at block 2640. In some embodiments, disconnecting the ventilator atblock 2635 includes loosening the ventilator coupling element 114 forone hand removal and then removing the ventilator coupling element withone hand while standing at the patient's side at chest level after theventilator is disconnected. The endotracheal tube cleaning device 120can be inserted at block 2640 in a single-hand operation using the otherhand (the hand not used to remove the ventilator coupling element 114).

The cleaning member 126 can then be deployed at block 2645 (e.g., with aone-hand activation of the actuation assembly 124) and the endotrachealtube cleaning device 120 can then be withdrawn from the endotrachealtube 100 while applying counter-traction to the endotracheal tube 100itself at block 2650. The endotracheal tube cleaning device 120 can bewithdrawn over a one to three second time period. In other embodiments,withdrawal of the cleaning device can be faster than one second orlonger than three second, as desired, required or permitted for aparticular application or use. The removed endotracheal tube cleaningdevice 120 can be placed on a chux and wrapped up for biohazard disposalor reinserted into the original peel pouch and placed in a biohazardcollection unit. In one embodiment, the patient is then reconnected tothe ventilator at block 2655 after reconnecting the ventilator couplingelement 114

The steps of the endotracheal tube cleaning process 2600 described abovecan be repeated multiple times as necessary at a single treatment withthe endotracheal tube cleaning device 120, so long as the patient'sheart rate, heart rhythm, blood pressure, and O₂ saturation remainstable. The endotracheal tube cleaning process 2600 can be performed bya single person or by multiple persons. For example, a first person(e.g., nurse or respiratory therapist) can perform the cleaning with theendotracheal tube cleaning device and a second person (e.g., an ICUtechnician) can disconnect and reconnect the ventilator, remove theendotracheal tube cleaning device from its packaging, and dispose of theused endotracheal tube cleaning device.

In some embodiments, endotracheal tube cleaning methods can be performedduring a daily extubation attempt. FIG. 27 illustrates one embodiment ofa daily extubation process 2700 in which the endotracheal tube cleaningdevice 120 can be utilized.

With reference to the embodiment of a daily extubation process 2700illustrated by the flowchart in FIG. 27, the clinician performs aninitial assessment 2705 to ensure that the patient is in a stablecondition. The clinician can ensure that no hemodynamic or respirationsystem acute clinical changes exist that would make that system apriority. Next, the clinician discontinues or reverses sedatingmedications 2710 that may interfere with spontaneous ventilation and/ormedications that may produce a paralytic effect.

With continued reference to the procedure illustrated in FIG. 27, atblock 2715, the clinician performs a neurological examination to be surethat the patient is alert and able to follow commands. As indicated atblock 2720, the patient can be positioned semi-upright (e.g., the headof the bed is elevated to at least approximately 30 degrees relative tohorizontal). In some embodiments, the patient is then oxygenated at 100%FiO₂ or nearly 100% FiO₂ for approximately ten minutes at block 2725(pre-cleaning ventilation). In other embodiments, the patient isoxygenated for more or less than ten minutes as desired and/or required.

In some embodiments, as illustrated at block 2730, the ventilatorcoupling element 114 is removed and an introduction connector (e.g.,adapter 340) is placed between the endotracheal tube 100 and theventilator. At block 2735, endotracheal suctioning can be performed toaspirate pooled secretions from the major segments of thetracheobronchial tree. According to some embodiments, the patient isthen oxygenated again at 100% FiO₂ or nearly 100% FiO₂ for ten minutes,as illustrated at block 2740. In other embodiments, the patient isoxygenated for more or less than ten minutes as desired and/or required.

According to some embodiments, as illustrated at block 2745, theclinician can insert the endotracheal tube cleaning device 120 throughthe introduction connector after setting a maximum insertion depth withthe movable stop 322 based on the length of the endotracheal tube to becleaned. With reference to block 2750 of the flowchart of FIG. 27, thecleaning member 127 can be expanded by activating the actuation assembly124 to the appropriate setting corresponding to the predetermined innerdiameter of the endotracheal tube.

At block 2755 of FIG. 27, the endotracheal tube cleaning device 120,including the introduction connector which may be used to contain thebiofilm, can be withdrawn from the endotracheal tube. Then, the patientcan be reconnected to the ventilator at block 2760 after reconnectingthe ventilator coupling element 114. At block 2765, ventilator weaningcan be performed for approximately ten minutes. In some embodiments, theventilator weaning period advantageously allows time for improvedventilation/perfusion match to occur following removal of theendotracheal tube cleaning device 120.

In some embodiments, any or all of the steps in the daily extubationprocess 2700 can be repeated. In other embodiments, one or more stepscan be removed, modified, or altered without departing from the spiritand/or scope of the disclosure. The daily extubation process 2700 can beperformed by a single person and/or multiple persons.

FIG. 28 illustrates an embodiment of a process 2800 for preventing thebuildup of biofilm inside an endotracheal tube. The process 2800 beginsat block 2805, where an initial assessment of a patient's risk factorsfor biofilm buildup and VAP is performed. Also at block 2805, anintervention plan can be created based at least in part on clinicalparameters, such as oxygen saturation levels. At block 2810, thepatient's airway and/or endotracheal tube is viewed using avisualization or imaging element.

In some embodiments, the patient is then prepared for endotracheal tubecleaning by oxygenating the patient at block 2815. For example, thepatient can be oxygenated for approximately ten minutes or other desiredtime period at a 100% or nearly 100% oxygen saturation level. At block2820, an endotracheal tube cleaning can be performed by inserting anendotracheal tube cleaning device (e.g., endotracheal tube cleaningdevice 120) into the endotracheal tube and then removing it. At block2825, biofilm removed by the endotracheal tube cleaning device can beoptionally sampled. With reference to block 2830 of the flowchart ofFIG. 28, the clinician identifies the drugs that are most appropriatefor preventing biofilm buildup and/or treating the bacteria present inthe biofilm sample.

According to some embodiments, at block 2835, the identified drugs aredelivered to the endotracheal tube and/or to the native airway of thepatient. In some embodiments, the drugs are delivered through aninternal lumen of the endotracheal tube cleaning device 120. In otherembodiments, the drugs are delivered using a drug delivery catheterwithout the use of the endotracheal tube cleaning device 120. Thedelivery of the identified drugs can be repeated according to apredetermined delivery schedule as desired and/or required.

D. Artificial Biofilm for Training

In some embodiments, an artificial biofilm can be constructed tosimulate the build up and distribution of biofilm for the purposes oftraining ICU personnel “best practices” for identifying, removing,sampling, culturing, suctioning or lavaging of actual biofilm. Theartificial biofilm can comprise one or more of the following: slime,gelatin, glycerin, petroleum, egg whites, hair spray or hair gel, andlike materials, and combinations thereof. In one embodiment, theartificial biofilm comprises a gelatinous material with a texture anddensity that mimics natural mucous. The artificial biofilm can beinserted into a standard endotracheal tube positioned within a model ofa human airway. The artificial biofilm can be inserted using a syringeand catheter, for example.

In some embodiments, the artificial biofilm can be inserted so as tosimulate typical patient conditions after prolonged ventilation (e.g.,greater than 24 hours). For example, little to no artificial biofilm canbe inserted in the first 2.5 cm from the distal tip of the endotrachealtube, a 0.1 mm thick layer of artificial biofilm can be inserted alongthe inner surface of the main collection region of the endotrachealtube, and a 0.5 mm thick layer of artificial biofilm can be insertedalong the inner surface of the endotracheal tube from the maincollection region to the proximal end of the endotracheal tube.

The training of the ICU personnel using the artificial biofilm can beperformed with or without a visualization element. If the training isperformed without the visualization element, the endotracheal tubecleaning device can be inserted, deployed, and removed as describedabove. If the training is performed with the visualization element, theimages provided by the visualization element can be displayed forviewing by multiple ICU personnel and/or can be recorded for subsequenttraining.

The use of the artificial biofilm can aid in demonstrating the effect ofan occluded endotracheal tube on oxygen saturation levels. Theartificial biofilm can also be used to train ICU personnel on thevisualization, sampling, suction, and/or cleaning features of theendotracheal tube cleaning devices, systems and methods describedherein. The use of the artificial biofilm to train ICU personneladvantageously allows for simulated role play without compromisingpatient safety.

X. Other Uses

In some embodiments, the endotracheal tube cleaning device 120 can beinserted into a patient's endotracheal tube at the time of apercutaneous tracheostomy. A percutaneous tracheostomy may be performed,for example, if a patient cannot be weaned after a sufficiently longperiod of time or if the patient's normal airway is obstructed. If anendotracheal tube is left in the patient for extended time periods,polyps or scarring can develop within the patient's airways. Thus, aclinician or other patient care provider may decide to convert from anendotracheal tube to a tracheostomy tube.

In some embodiments, a percutaneous tracheostomy comprises inserting ahollow needle 3602 within the trachea 3604 through an incision formed ata position between the patient's larynx 3606, or Adam's Apple, and thepatient's sternal notch 3608, as shown in FIG. 36. Currently, patientcare providers determine proper positioning of the hollow needle 3602during a percutaneous tracheostomy by the ability to aspirate. However,such tests are not always accurate, because air can be entering from theesophagus. In some embodiments, a guidewire 3612 is inserted through thehollow needle 3602 to facilitate the introduction of tracheostomydilators and eventually the tracheostomy tube. Without the assistance ofvisualization, the hollow needle 3602 can be inadvertently insertedthrough a distal end of an indwelling endotracheal tube 3610, whichgenerally remains within the patient until the tracheostomy iscompleted. In addition, without visualization, the guidewire 3612 canbecome tied to the endotracheal tube 3610, thereby preventing properinsertion of dilators and/or a tracheostomy tube over the guidewire 3612and preventing removal of the endotracheal tube 3610.

In many instances, bronchoscopes are currently used to providevisualization. However, bronchoscopes have a relatively large diameterthat substantially obstructs the patient's airway during use. Inaddition, the cost of the bronchoscopes prohibitively preventssingle-use, disposable visualization devices. Thus, resterilization andcleansing of bronchoscopes is required.

In some embodiments, the endotracheal tube cleaning devices describedherein can be used to visualize the trachea 3604 during the percutaneoustracheostomy in order to verify and confirm proper insertion andpositioning of any needles, guidewires, tubes, and/or balloons withinthe trachea 3604. The use of the visualization features of theendotracheal tube cleaning devices described herein advantageouslyallows for conversion to a tracheostomy while keeping the patientconnected to an external ventilator. In some embodiments, as describedabove, the visualization element (e.g., a visualization scope 142, 3342)can record one or more images of the trachea 3604 to document the properpositioning and/or insertion of the various devices inserted within thetrachea 3604 through the percutaneous tracheostomy. Recordings,according to some embodiments, are then uploaded or transmitted (e.g.,via wired or wireless network communication) to a communication device,database, network, printer or other device for communicating ormemorializing that the proper position was confirmed.

The endotracheal tube cleaning device 120 can be inserted within theendotracheal tube 3610 through a standard T adaptor or connector (forexample, as currently used for bronchoscopy) or through a proprietaryadapter or connector having an inlet visualization port sized and shapedto conform to the outer diameter of the endotracheal tube cleaningdevice 120. In some embodiments, the inlet visualization port can becovered by an elastomeric plug having an opening having a smallerdiameter than the opening of the standard T adaptor or connector, suchas a Portex® Fiberoptic Bronchoscope Swivel Adapter commerciallyavailable from Smiths Medical ASD, Inc. The opening of the elastomericplug can be sized to substantially match or conform to the outerdiameter of the endotracheal tube cleaning device 120. The T adapter orconnector can include a side inlet port for connection to an externalventilator, thereby allowing the patient to continue to be supportedwith supplemental oxygen during the conversion to the percutaneoustracheostomy.

Although the endotracheal tube cleaning devices, methods, and systemsdescribed herein have been described in connection with the cleaning ofendotracheal tubes or other body-inserted tubes, the embodiments andfeatures described herein can be used for other medical applications,such as, for example, the cleaning of catheters, probes, body lumens,vasculature (e.g., arteries and veins), urinary tracts, grafts (e.g.,hemodialysis grafts, vascular grafts), aspiration conduits, ventilationtubes, and the like. Non-medical applications of the devices, methods,and systems described herein include, but are not limited to, thecleaning of pipes, hoses, guns, ventilation ducts and any other hollowor substantially hollow structure and/or the like.

XI. Functionality

In one embodiment, the endotracheal tube cleaning device 120 is a fullydisposable, single-use device. In other embodiments, one or morecomponents or portions of the endotracheal tube cleaning device 120 areselectively detachable and configured for reuse. For example, theelongate body 122 and the actuation member 124 can be reusable, whilethe cleaning member 126 can be detachable and disposable. In someembodiments, the spent endotracheal tube cleaning device 120 isdeposited in a biohazardous container after removal. In someembodiments, the endotracheal tube cleaning device 120 can performmultiple cleaning passes for a single patient before being disposed.

According to some embodiments, the endotracheal tube cleaning device 120is configured for single-handed operation by a single practitioner. Inalternative embodiments, the endotracheal tube cleaning device 120 canbe operated using two hands or by multiple practitioners.

In some embodiments, the endotracheal tube cleaning device 120 isconfigured to be single-pass device that clears or removes up to 90% ofmore of the biofilm. In other embodiments, a single pass device can bedesigned and otherwise configured to remove more or less than 90% ofbiofilm, as desired and/or required.

In other embodiments, such as when the endotracheal tube has been in thepatient for multiple days without being cleaned and/or more than about15 ccs of biofilm has accumulated within the endotracheal tube, multiplepasses may be performed to remove the biofilm. The determination as towhether to perform additional cleaning passes can be made usingvisualization devices inserted within the endotracheal tube, asdescribed herein, or by visual inspection of the cleaning member 126upon removal of the endotracheal tube cleaning device 120. For example,if the capacity of the collection mechanism of the endotracheal tubecleaning device 120 visually appears to have been reached and/orexceeded, another pass may be desirable.

According to some embodiments, the endotracheal tube cleaning device 120is provided in a pouch or tray and is sterile ready to use. In otherembodiments, the endotracheal tube cleaning device 120 can be providedsterilized or clean ready to use. In one embodiment, the endotrachealtube cleaning device 120 is provided in a disposable peel-pack or pouch.At least one sleeve of the peel-pack can be used for disposal of thespent endotracheal tube cleaning device 120 and the removed biofilm.

In some embodiments, the insertion and removal of the endotracheal tubecleaning device 120 can be completed in less than about ten seconds,with 90% of the biofilm being removed. However, as discussed herein, thetime period for completing a procedure and/or the exact amount ofbiofilm removed from a cleaning procedure can vary, as desired orrequired. For example, in one embodiment, the insertion of theendotracheal tube cleaning device 120 can be performed in less than twoseconds and the removal of the endotracheal tube cleaning device 120 canbe performed in one to three seconds.

In some embodiments, the endotracheal tube cleaning device 120 can betwisted or rotated manually by a clinician to enhance the wiping actionof the removal member 132 (e.g., O-ring). In other embodiments, theremoval member 132 (e.g., O-ring) and/or the collection member 134(e.g., mesh scaffold) have one or more driving mechanisms to effectuatea tangential wiping motion in addition to the pulling wiping motion ofthe cleaning member 126. Still other embodiments include a screwmechanism so that the cleaning member 126 twists as the endotrachealtube cleaning device 120 is withdrawn.

Conditional language, for example, among others, “can,” “could,”“might,” or “may,” unless specifically stated otherwise, or otherwiseunderstood within the context as used, is generally intended to conveythat certain embodiments include, while other embodiments do notinclude, certain features, elements and/or steps. Thus, such conditionallanguage is not generally intended to imply that features, elementsand/or steps are in any way required for one or more embodiments or thatone or more embodiments necessarily include logic for deciding, with orwithout user input or prompting, whether these features, elements and/orsteps are included or are to be performed in any particular embodiment.

Although certain embodiments and examples have been described herein, itwill be understood by those skilled in the art that many aspects of themethods and devices shown and described in the present disclosure may bedifferently combined and/or modified to form still further embodiments.Additionally, it will be recognized that the methods described hereinmay be practiced using any device suitable for performing the recitedsteps. Some embodiments have been described in connection with theaccompanying drawings. However, it should be understood that the figuresare not drawn to scale. Distances, angles, etc. are merely illustrativeand do not necessarily bear an exact relationship to actual dimensionsand layout of the devices illustrated. Components can be added, removed,and/or rearranged. Additionally, the skilled artisan will recognize thatany of the above-described methods can be carried out using anyappropriate apparatus. Further, the disclosure herein of any particularfeature, aspect, method, property, characteristic, quality, attribute,element, or the like in connection with various embodiments can be usedin all other embodiments set forth herein. Additionally, process stepsmay be added, removed, or reordered. A wide variety of designs andapproaches are possible.

For purposes of this disclosure, certain aspects, advantages, and novelfeatures of the inventions are described herein. It is to be understoodthat not necessarily all such advantages may be achieved in accordancewith any particular embodiment of the inventions. Thus, for example,those skilled in the art will recognize that the inventions may beembodied or carried out in a manner that achieves one advantage or groupof advantages as taught herein without necessarily achieving otheradvantages as may be taught or suggested herein.

What is claimed is:
 1. A non-inflatable, mechanically-actuated cleaning device for removing biofilm from an interior wall of an endotracheal tube, comprising: an elongate body having a distal end, a proximal end and a longitudinal axis, wherein the distal end comprises a distal tip; a cleaning member positioned at the distal end of the elongate body, said cleaning member comprising an expansion member and an elastomeric sleeve extending along at least a portion of the exterior surface of the expansion member, wherein said cleaning member is selectively movable between a radially-collapsed position and a radially-expanded position, wherein a central portion of the elastomeric sleeve forms a removal member configured to engage an interior surface of an endotracheal tube when the cleaning member is in the radially-expanded position, wherein said removal member is configured to remove biofilm collected on the interior surface of an endotracheal tube when said removal member is moved along the longitudinal axis of the elongate body; and a non-inflatable actuation assembly coupled to the proximal end of the elongate body, wherein said cleaning member is movable between said radially-collapsed position and said radially-expanded position by manipulation of the actuation assembly, and wherein the expansion and collapse of the cleaning member occurs mechanically.
 2. The cleaning device of claim 1, wherein the expansion member comprises an expandable mesh scaffold, wherein said scaffold is configured to expand the elastomeric sleeve to form the removal member in the radially-expanded position.
 3. The cleaning device of claim 1, wherein the actuation assembly is configured to permit a user to modify radial expansion of the cleaning member in order to modify a pressure exerted by the removal member on an inside surface of an endotracheal tube or on a biofilm deposited on an inside surface of an endotracheal tube.
 4. The cleaning device of claim 1, wherein the elongate body comprises an inner shaft and an outer shaft, wherein movement of the inner shaft relative to the outer shaft moves the cleaning member between collapsed and expanded radial positions.
 5. The cleaning device of claim 1, further comprising a first air gap along a proximal end of the elastomeric sleeve and a second air gap along a distal end of the elastomeric sleeve, wherein the first and second air gaps facilitate the passage of air across the cleaning member.
 6. The cleaning device of claim 1, wherein the expansion member comprises one or more mechanically-expandable struts.
 7. The cleaning device of claim 1, wherein said elongate body comprises at least one interior lumen that extends along said longitudinal axis to a distal end of the cleaning device.
 8. The cleaning device of claim 7, wherein the at least one interior lumen is configured to receive a visualization scope, and wherein the distal tip of the cleaning device comprises a viewing window.
 9. The cleaning device of claim 8, further comprising a scope retention assembly coupled to the actuation assembly, the scope retention assembly being configured to exert a static backward force on the visualization scope in the direction of the distal end of the cleaning device.
 10. The cleaning device of claim 9, wherein a distal end of the visualization scope is maintained in generally constant contact with the viewing window of the cleaning device using the scope retention assembly.
 11. The cleaning device of claim 9, wherein the scope retention assembly comprises an elastomeric sheath and a scope retention member.
 12. The cleaning device of claim 11, wherein the elastomeric sheath is configured to stretch to allow the scope retention member to receive a locking member disposed on the visualization scope, thereby providing the static backward force on the visualization scope.
 13. The cleaning device of claim 1, wherein the ratio of the width of the removal member to the overall length of the elastomeric sleeve is between about 1:5 and about 2:5.
 14. The cleaning device of claim 1, wherein the ratio of the width of the apex to the width of the base of the removal member is between about 1:3 and about 1:4.
 15. The cleaning device of claim 1, wherein a width of the base of the removal member is between about 0.10 and about 0.80 inches.
 16. The cleaning device of claim 1, wherein a length of the elastomeric sleeve decreases by about 15% to about 30% when the cleaning member is moved from the radially-collapsed position to radially-expanded position.
 17. The cleaning device of claim 1, wherein the removal member comprises a generally disc-shape when the cleaning member is in the radially-expanded position.
 18. The cleaning device of claim 1, wherein the removal member comprises a generally diamond shape when the cleaning member is in the radially-expanded position.
 19. The cleaning device of claim 1, wherein the removal member comprises a generally smooth apex when the expandable structure is in the radially-expanded position, said apex being configured to at least partially contact an inside surface of the endotracheal tube.
 20. The cleaning device of claim 1, wherein at least a portion of the elastomeric sleeve is configured to radially expand together with the expansion member when the expansion member moves from the radially-collapsed position to the radially-expanded position. 